FDA 510(k) Applications for Medical Device:
Single (Specified) Analyte Controls (Assayed And Unassayed)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K143026 | AALTO SCIENTIFIC LTD. |
1959 KELLOGG AVE. | CARLSBAD | CA | 92008 |
| K100750 | AALTO SCIENTIFIC LTD. |
1959 KELLOGG AVE. | CARLSBAD | CA | 92008 |
| K130157 | AALTO SCIENTIFIC LTD. |
1959 KELLOGG AVE. | CARLSBAD | CA | 92008 |
| K100715 | AALTO SCIENTIFIC LTD. |
1959 KELLOGG AVE. | CARLSBAD | CA | 92008 |
| K101427 | AALTO SCIENTIFIC LTD. |
1959 KELLOGG AVE. | CARLSBAD | CA | 92008 |
| K112143 | AALTO SCIENTIFIC LTD. |
1959 KELLOGG AVE. | CARLSBAD | CA | 92008 |
| K130764 | AALTO SCIENTIFIC LTD. |
1959 KELLOGG AVE. | CARLSBAD | CA | 92008 |
| K161874 | AALTO SCIENTIFIC, LTD. |
230 TECHNOLOGY PARKWAY | EATONTON | GA | 30642 |
| K143571 | AALTO SCIENTIFIC, LTD. |
1959 KELLOGG AVE. | CARLSBAD | CA | 92008 |
| K970527 | ABBOTT LABORATORIES |
100 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-3500 |
| K041687 | ABBOTT LABORATORIES |
100 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-3500 |
| K112653 | ACON LABORATORIES, INC. |
10125 MESA RIM RD. | SAN DIEGO | CA | 92121 |
| K960378 | ACTIMED LABORATORIES, INC. |
5 TERRI LN. | BURLINGTON | NJ | 08016 |
| K083549 | AMERICAN BIOLOGICAL TECHNOLOGIES, INC. |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K091460 | AMERICAN BIOLOGICAL TECHNOLOGIES, INC. |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K090854 | AMERICAN BIOLOGICAL TECHNOLOGIES, INC. |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K090943 | AMERICAN BIOLOGICAL TECHNOLOGIES, INC. |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K991075 | AMIRA MEDICAL, INC. |
4742 SCOTTS VALLEY DR. | SCOTTS VALLEY | CA | 95066 |
| K100747 | APEX BIO TECHNOLOGY CORP |
NO. 7, LI-HSIN ROAD V | HSINCHU | 30078 | |
| K001651 | AXIS-SHIELD BIOCHEMICALS, ASA |
P.O. BOX 262069 | SAN DIEGO | CA | 92196 |
| K020217 | BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K151742 | BAYER HEALTHCARE |
430 SOUTH BEIGER STREET | MISHAWAKA | IN | 46544 |
| K981864 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K993210 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K112603 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K994200 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K994277 | BECKMAN COULTER, INC. |
7330 CARROLL RD. | SAN DIEGO | CA | 92196 |
| K010428 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K001458 | BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 | BREA | CA | 92822-8000 |
| K010693 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K982022 | BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD.,M/S W-104 | BREA | CA | 92822-8000 |
| K962694 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K973832 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K962841 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K955468 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K961206 | BEHRING DIAGNOSTICS, INC. |
151 UNIVERSITY AVE. | WESTWOOD | MA | 02090 |
| K990162 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K992781 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K984626 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K990608 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K984604 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K984625 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K984319 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K984070 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K984318 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K984323 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K990393 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K984324 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K983578 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K984073 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K984327 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618 |
| K984072 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K042837 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K984071 | BIO-RAD |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K961432 | BIO-RAD |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547-1803 |
| K123798 | Bio-Rad Laboratories |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K043584 | BIO-RAD LABORATORIES, INC. |
9500 JERONIMO RD. | IRVINE | CA | 92618-2017 |
| K963551 | BIOCELL LABORATORIES, INC. |
2001 UNIVERSITY DR. | RANCHO DOMINGUEZ | CA | 90220-6411 |
| K000056 | BIOCELL LABORATORIES, INC. |
2001 UNIVERSITY DR. | RANCHO DOMINGUEZ | CA | 90220-6411 |
| K050328 | BIOCHEMICAL DIAGNOSTIC, INC. |
180 HEARTLAND BLVD. | BRENTWOOD | NY | 11717 |
| K060027 | BIOKIT S.A. |
LLISSA D'AMUNT | BARCELONA | 08186 | |
| K133003 | BIONIME CORPORATION |
55 NORTHERN BLVD. SUITE 200 | GREAT NECK | NY | 11021 |
| K002540 | BIONOSTICS, INC. |
2 CRAIG RD. | ACTON | MA | 01720 |
| K000318 | BIONOSTICS, INC. |
2 CRAIG RD. | ACTON | MA | 01720 |
| K021697 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01432 |
| K032819 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01432 |
| K013147 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01432 |
| K112352 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01434 |
| K112356 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01434 |
| K082395 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01434 |
| K081403 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01434 |
| K123966 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01434 |
| K113764 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01434 |
| K123851 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01434 |
| K131136 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01434 |
| K103553 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01434 |
| K022769 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01432 |
| K012430 | BIONOSTICS, INC. |
2 CRAIG RD. | ACTON | MA | 01720 |
| K091914 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01434 |
| K053327 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01434 |
| K021624 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01432 |
| K081478 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01434 |
| K050961 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01434 |
| K050100 | BIONOSTICS, INC. |
7 JACKSON RD. | DEVENS | MA | 01432 |
| K000230 | BIOSITE INCORPORATED |
11030 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K000231 | BIOSITE INCORPORATED |
11030 ROSELLE ST. | SAN DIEGO | CA | 92121 |
| K982471 | BOEHRINGER MANNHEIM CORP. |
4300 HACIENDA DR. | PLEASANTON | CA | 94588-2722 |
| K970452 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524-4117 |
| K970459 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524-4117 |
| K963182 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K970148 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524-4117 |
| K963163 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K963164 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K963165 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K964830 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524 |
| K970458 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524-4117 |
| K963181 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K963178 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K970146 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524-4117 |
| K963143 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K963147 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K974383 | BOEHRINGER MANNHEIM CORP. |
4300 HACIENDA DR. | PLEASANTON | CA | 94588-2722 |
| K962573 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524 |
| K963167 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K973358 | BOEHRINGER MANNHEIM CORP. |
4300 HACIENDA DR. | PLEASANTON | CA | 94588-2722 |
| K970984 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524 |
| K974811 | BOSTON BIOMEDICA, INC. |
375 WEST ST. | WEST BRIDGEWATER | MA | 02379 |
| K071648 | CANTERBURY SCIENTIFIC LTD. |
14 POPE STREET | CHRISTCHURCH | 8001 | |
| K043070 | CANTERBURY SCIENTIFIC LTD. |
14 POPE STREET | CHRISTCHURCH, CANTERBURY | 8001 | |
| K983432 | CHRONIMED, INC. |
10900 RED CIRCLE DR. | MINNETONKA | MN | 55343 |
| K961510 | CIBA CORNING DIAGNOSTICS CORP. |
17392 DAIMLER ST. | IRVINE | CA | 92714 |
| K962432 | CLINICAL CONTROLS, INC. |
750 FARROLL RD. | GROVER BEACH | CA | 93433 |
| K964278 | CLINICAL CONTROLS, INC. |
750 FARROLL RD. | GROVER BEACH | CA | 93433 |
| K121237 | CLINIQA CORPORATION |
288 DISTRIBUTION STREET | SAN MARCOS | CA | 92078 |
| K052679 | CLINIQA CORPORATION |
1432 SOUTH MISSION RD. | FALLBROOK | CA | 92028 |
| K041898 | CLINIQA CORPORATION |
1432 SOUTH MISSION ROAD | FALLBROOK | CA | 92028 |
| K022232 | CLINIQA CORPORATION |
1432 SOUTH MISSION RD. | FALLBROOK | CA | 92028 |
| K022491 | CLINIQA CORPORATION |
1432 SOUTH MISSION RD. | FALLBROOK | CA | 92028 |
| K022758 | CLINIQA CORPORATION |
1432 SOUTH MISSION RD. | FALLBROOK | CA | 92028 |
| K040927 | CLINIQA CORPORATION |
1432 SOUTH MISSION RD. | FALLBROOK | CA | 92028 |
| K040455 | CLINIQA CORPORATION |
1432 SOUTH MISSION RD. | FALLBROOK | CA | 92028 |
| K060570 | COMPASS BIOSCIENCE |
1850 EVERGREEN ST. | DUARTE | CA | 91010-2906 |
| K121534 | CONE BIOPRODUCTS |
1012 N. AUSTIN ST. | SEGUIN | TX | 78155 |
| K052010 | CONE BIOPRODUCTS |
1008 N. RIVER ST. | SEGUIN | TX | 78155 |
| K981622 | DADE BEHRING, INC. |
1851 DELAWARE PKWY. | MIAMI | FL | 33125 |
| K982591 | DADE BEHRING, INC. |
1851 DELAWARE PKWY. | MIAMI | FL | 33125 |
| K013130 | DADE BEHRING, INC. |
GLASGOW SITE | NEWARK | DE | 19714-6101 |
| K973099 | DADE CHEMISTRY SYSTEMS, INC. |
GLASGOW SITE | NEWARK | DE | 19714-6101 |
| K972287 | DADE INTL., INC. |
2173 NW 99TH AVE. | MIAMI | FL | 33172 |
| K955796 | DATA MEDICAL ASSOCIATES, INC. |
845 AVENUE G EAST | ARLINGTON | TX | 76011 |
| K983971 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K963240 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K971051 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K962975 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K960154 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K161526 | DiaSorin Inc. |
1951 Northwestern Avenue | Stillwater | MN | 555082 |
| K161522 | DiaSorin Inc. |
1951 Northwestern Ave. | Stillwater | MN | 55082-0285 |
| K090104 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K093498 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082 |
| K092911 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K963909 | DIRECT SOLUTIONS |
7 HAYRICK LN. | WESTFORD | MA | 01886 |
| K964053 | DIRECT SOLUTIONS |
7 HAYRICK LN. | WESTFORD | MA | 01886 |
| K060510 | DREW SCIENTIFIC LTD. |
SOWERBY WOODS BUSINESS PARK | BARROW IN FURNESS CUMBRIA | LA14 4QR | |
| K060215 | EUROTROL B.V. |
40 EMPIRE DRIVE | LAKE FOREST | CA | 92630 |
| K080273 | FUJIREBIO DIAGNOSTICS TEXAS, INC. |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K081915 | FUJIREBIO DIAGNOSTICS TEXAS, INC. |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K110436 | FUJIREBIO DIAGNOSTICS, INC |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K103450 | FUJIREBIO DIAGNOSTICS, INC |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K102260 | FUJIREBIO DIAGNOSTICS, INC |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K110641 | FUJIREBIO DIAGNOSTICS, INC |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K092645 | FUJIREBIO DIAGNOSTICS, INC. |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K123612 | FUJIREBIO DIAGNOSTICS, INC. |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K133197 | FUJIREBIO DIAGNOSTICS, INC. |
940 CROSSROADS BLVD | SEGUIN | TX | 78155 |
| K042448 | GENERAL ATOMICS |
3550 GENERAL ATOMICS COURT | SAN DIEGO | CA | 92121 |
| K022725 | GOOD BIOTECH CORP. |
38, 34TH RD. | TAICHUNG | 407 | |
| K974609 | HELENA LABORATORIES |
1530 LINDBERGH DR. | BEAUMONT | TX | 77704 |
| K042080 | HOME DIAGNOSTICS, INC. |
2400 N.W. 55TH CT. | FORT LAUDERDALE | FL | 33309 |
| K031873 | I-STAT CORPORATION |
104 WINDSOR CENTER DR. | EAST WINDSOR | NJ | 08520 |
| K161082 | IMMUNODIAGNOSTIC SYSTEMS LTD. |
10 DIDCOT WAY, | BOLDON | NE35 9PD | |
| K111650 | IMMUNODIAGNOSTIC SYSTEMS LTD. |
10 DIDCOT WAY, | BOLDON, TYNE & WEAR | NE35 9PD | |
| K143324 | IMMUNODIAGNOSTIC SYSTEMS LTD. |
10 DIDCOT WAY, | BOLDON, TYNE & WEAR | NE35 9PD | |
| K110412 | IMMUNODIAGNOSTIC SYSTEMS LTD. |
10 DIDCOT WAY, | BOLDON, TYNE & WEAR | NE35 9PD | |
| K122141 | IMMUNODIAGNOSTIC SYSTEMS LTD. |
10 DIDCOT WAY, | BOLDON, TYNE & WEAR | NE35 9PD | |
| K111938 | IMMUNODIAGNOSTIC SYSTEMS LTD. |
10 DIDCOT WAY, | BOLDON, TYNE & WEAR | NE35 9PD | |
| K963085 | INTERNATIONAL ENZYMES, INC. |
772-F NORTH TWIN OAKS VALLEY, | SAN MARCOS | CA | 92069 |
| K970176 | INTERNATIONAL NEWTECH DEVELOPMENT, INC. |
150-13500 MAYCREST WAY | RICHMOND, B.C. | V6V 2N8 | |
| K050983 | INTERNATIONAL TECHNIDYNE CORPORATION |
2656 PATTON RD. | ROSEVILLE | MN | 55113 |
| K071587 | INVERNESS MEDICAL INNOVATIONS, INC. |
51 SAWYER RD., SUITE 200 | WALTHAM | MA | 02453 |
| K060133 | INVERNESS MEDICAL INNOVATIONS, INC. |
51 SAWYER RD., SUITE 200 | WALTHAM | MA | 02453-3448 |
| K974644 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14650-0882 |
| K060481 | LIBERTY HEALTHCARE GROUP, INC. |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K052980 | LIBERTY HEALTHCARE GROUP, INC. |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K060426 | LIBERTY HEALTHCARE GROUP, INC. |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K060706 | LIBERTY HEALTHCARE GROUP, INC. |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K063855 | LIBERTY HEALTHCARE GROUP, INC. |
940 CROSSROADS BLVD. | SEGUIN | TX | 78155 |
| K971014 | LIFESCAN, INC. |
1000 GIBRALTAR DR. | MILPITAS | CA | 95035-6312 |
| K955629 | LXN CORP. |
5830 OBERLIN DR. | SAN DIEGO | CA | 92121 |
| K012122 | MAINE STANDARDS CO. |
765 ROOSEVELT TRAIL | WINDHAM | ME | 04062-5365 |
| K013119 | MAINE STANDARDS CO. |
765 ROOSEVELT TRAIL | WINDHAM | ME | 04062-5365 |
| K123127 | MAINE STANDARDS CO. |
765 ROOSEVELT TRAIL | WINDHAM | ME | 04062-5365 |
| K062501 | MAINE STANDARDS CO. |
765 ROOSEVELT TRAIL | WINDHAM | ME | 04062-5365 |
| K113524 | MAINE STANDARDS CO. |
765 ROOSEVELT TRAIL | WINDHAM | ME | 04062-5365 |
| K133550 | MAINE STANDARDS COMPANY LLC |
221 US ROUTE 1 | CUMBERLAND FORESIDE | ME | 04110 |
| K041194 | MEDICAL ANALYSIS SYSTEMS, INC. |
5300 ADOLFO RD. | CAMARILLO | CA | 93012 |
| K031890 | MEDICAL ANALYSIS SYSTEMS, INC. |
5300 ADOLFO RD. | CAMARILLO | CA | 93012 |
| K023307 | MEDICAL ANALYSIS SYSTEMS, INC. |
5300 ADOLFO RD. | CAMARILLO | CA | 93012 |
| K042717 | MEDICAL ANALYSIS SYSTEMS, INC. |
5300 ADOLFO RD. | CAMARILLO | CA | 93012 |
| K070506 | MEDICAL SPECIALTIES SUPPLY CO., INC. |
1755 EAST BIRCHWOOD AVE. | DES PLAINES | IL | 60018 |
| K092749 | Microgenics Corporation |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K970778 | MORE DIAGNOSTICS |
2216 SUNSET DR. | LOS OSOS | CA | 93402 |
| K030849 | N-DIA, INC. |
30 E. 20TH ST., STE. 501 | NEW YORK | NY | 10003 |
| K033433 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K041016 | NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. | WALTHAM | MA | 02454-9141 |
| K033127 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K042303 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K012561 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K011463 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K013900 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K990061 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14650-0882 |
| K032993 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K003112 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K990783 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K990984 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K984011 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K990026 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K011250 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K003095 | Qualigen, Inc. |
2042 CORTE DEL NOGAL | CARLSBAD | CA | 92009 |
| K062957 | Qualigen, Inc. |
2042 CORTE DEL NOGAL | CARLSBAD | CA | 92011 |
| K113177 | QUANTIMETRIX CORP. |
2005 MANHATTAN BEACH BLVD. | REDONDO BEACH | CA | 90278-1205 |
| K103744 | QUANTIMETRIX CORP. |
2005 MANHATTAN BEACH BLVD. | REDONDO BEACH | CA | 90278-1205 |
| K152117 | Quantimetrix Corporation |
2005 Manhattan Beach Blvd | Redondo Beach | CA | 90278 |
| K974108 | QUIDEL CORP. |
10165 MCKELLAR CT. | SAN DIEGO | CA | 92121 |
| K034048 | R & D SYSTEMS, INC. |
614 MCKINLEY PL., N.E. | MINNEAPOLIS | MN | 55413 |
| K131776 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K131999 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K121588 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K040351 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K121746 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K972721 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 | BRANCHBURG | NJ | 08876-3771 |
| K170678 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K100810 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K111349 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K080643 | Roche Diagnostics |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K102086 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K122242 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K101856 | Roche Diagnostics |
9115 HAGUE RD | INDIANAPOLIS | IN | 46250 |
| K133284 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K093582 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K162173 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K103402 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K102044 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K143284 | ROCHE DIAGNOSTICS |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250 |
| K142127 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K102267 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K094031 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K092168 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250 |
| K121895 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K102269 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K121279 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K112113 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K112104 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K140534 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K092169 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K150955 | ROCHE DIAGNOSTICS |
ROCHE PROFESSIONAL DIAGNOSTICS | INDIANAPOLIS | IN | 46250 |
| K110613 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K103162 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K090311 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K092585 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K111552 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K083655 | Roche Diagnostics |
9115 SOUTH HAGUE ROAD | INDIANAPOLIS | IN | 46250 |
| K100594 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250 |
| K093836 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K103099 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K053059 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K003967 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K020369 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K001014 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K000042 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K040157 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K101365 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD | INDIANAPOLIS | IN | 46250-0457 |
| K003772 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K093700 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0416 |
| K010237 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K001846 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K101075 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0416 |
| K993642 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K031990 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K020883 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K080147 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K001015 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K092888 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K092848 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0416 |
| K091601 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K031698 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K043320 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K062972 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0416 |
| K112528 | ROCHE DIAGNOSTICS CORPORATION |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K981278 | ROCHE DIAGNOSTICS GMBH |
4300 HACIENDA DR. | PLEASANTON | CA | 94566-0900 |
| K981281 | ROCHE DIAGNOSTICS GMBH |
4300 HACIENDA DR. | PLEASANTON | CA | 94566-0900 |
| K990720 | SA SCIENTIFIC, INC. |
4919 GOLDEN QUAIL | SAN ANTONIO | TX | 78240 |
| K990755 | SA SCIENTIFIC, INC. |
4919 GOLDEN QUAIL | SAN ANTONIO | TX | 78240 |
| K030628 | SA SCIENTIFIC, INC. |
4919 GOLDEN QUAIL | SAN ANTONIO | TX | 78240 |
| K092993 | SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K091123 | SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K110061 | SIEMENS HEALTHCARE DIAGNOSTICS |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591-5097 |
| K102904 | SIEMENS HEALTHCARE DIAGNOSTICS |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591-5097 |
| K143639 | Siemens Healthcare Diagnostics |
511 Benedict Avenue | Tarrytown | NY | 10591 |
| K150132 | Siemens Healthcare Diagnostics |
511 Benedict Avenue | Tarrytown | NY | 10591 |
| K103683 | SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K140267 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591-5097 |
| K140505 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591-5097 |
| K122534 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K131662 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K143504 | Siemens Healthcare Diagnostics Inc. |
511 Benedict Avenue | Tarrytown | NY | 10591 |
| K133816 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K142811 | Siemens Healthcare Diagnostics Inc. |
511 Benedict Avenue | Tarrytown | NY | 10591 |
| K131536 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K133122 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K141444 | Siemens Healthcare Diagnostics Inc. |
5210 PACIFIC CONCOURSE DRIVE | LOS ANGELES | CA | 90045 |
| K133128 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K133124 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K140541 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K140818 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K141772 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K121084 | Siemens Healthcare Diagnostics Inc. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K143376 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591 |
| K143194 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591 |
| K142864 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591 |
| K143687 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591 |
| K143680 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591 |
| K132739 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVE | TARRYTOWN | NY | 10591 |
| K143636 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
5210 Pacific Concourse Drive | Los Angeles | CA | 90045 |
| K142878 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
5210 Pacific Concourse Drive | Los Angeles | CA | 90045 |
| K140258 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K143352 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591 |
| K143373 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
5210 Pacific Concourse Drive | Los Angeles | CA | 90045 |
| K132391 | SIEMENS HELATHCARE DIAGNOSTICS INC. |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K973677 | SORRENTO BIOCHEMICAL, INC. |
3443 TRIPP CT., SUITE A | SAN DIEGO | CA | 92121 |
| K973676 | SORRENTO BIOCHEMICAL, INC. |
3443 TRIPP CT., SUITE A | SAN DIEGO | CA | 92121 |
| K973678 | SORRENTO BIOCHEMICAL, INC. |
3443 TRIPP CT., SUITE A | SAN DIEGO | CA | 92121 |
| K972687 | SPECTRAL DIAGNOSTICS, INC. |
135-2 THE WEST MALL | TORONTO, ONTARIO | M9C1C2 | |
| K070649 | SPECTRUM MEDICAL SUPPLY, INC. |
940 CROSSROADS BLVD | SEGUIN | TX | 78155 |
| K040025 | STRECK LABORATORIES, INC. |
7002 SOUTH 109TH ST. | LA VISTA | NE | 68128 |
| K001443 | STRECK LABORATORIES, INC. |
14124 INDUSTRIAL RD. | OMAHA | NE | 68145-0625 |
| K093724 | TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD | TAIPEI COUNTY | 248 | |
| K162514 | Technopath Manufacturing |
Fort Henry Business Park | Ballina | ||
| K981914 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K143296 | Tosoh BioScience, Inc. |
6000 Shoreline Court, Ste. 101 | South San Francisco | CA | 94080 |
| K041871 | TROUBLE SHOOTER CONSULING, INC. |
VIA RINA MONTI N 26 C.A.P. | ROME | 00155 | |
| K960874 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K040918 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K030065 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K973072 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
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