FDA 510(k) Applications for Medical Device:
Multi-Analyte Controls, All Kinds (Assayed)

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K143573 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K142978 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K032122 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K100718 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K102617 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K042318 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K062668 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K103601 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K070223 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K101216 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K101226 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K130762 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K082714 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K082717 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K111964 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K112742 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K112705 AALTO SCIENTIFIC LTD. 1959 KELLOGG AVE.
CARLSBAD CA 92008
K163629 Aalto Scientific, Ltd. 230 Technology Parkway
Eatonton GA 31024
K992710 ABBOTT LABORATORIES DEPT 9YC, BIDG. AP31
ABBOTT PARK IL 60064-6200
K102700 ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN 9975 Summers Ridge Road
San Diego CA 92121
K974822 AVL SCIENTIFIC CORP. 33 MANSELL COURT
ROSWELL GA 30076-4807
K001632 AVL SCIENTIFIC CORP. 235 HEMBREE PARK DR.
ROSWELL GA 30076
K030452 BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE.
TARRYTOWN NY 10591-5097
K033379 BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE.
TARRYTOWN NY 10591-5097
K061137 BAYER HEALTHCARE, LLC 511 BENEDICT AVE.
TARRYTOWN NY 10591-5097
K030801 BAYER HEALTHCARE, LLC 511 BENEDICT AVE.
TARRYTOWN NY 10591-5097
K031644 BAYER HEALTHCARE, LLC 511 BENEDICT AVE.
TARRYTOWN NY 10591
K013235 BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110
BREA CA 92822
K020521 BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD.,W-104
BREA CA 92822-8000
K003488 BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104
BREA CA 92822-8000
K993023 BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104
BREA CA 92822-8000
K982224 BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104
BREA CA 92822-8000
K010358 BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110
BREA CA 92822
K974452 BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD.
BREA CA 92821-6208
K964065 BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE.
WESTWOOD MA 02090
K955858 BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE.
WESTWOOD MA 02090
K990317 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K990017 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618
K990282 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K990161 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618
K990424 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K990150 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618
K990149 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618
K990391 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K990394 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K990610 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618
K011853 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K984325 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618
K984074 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K000875 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K050537 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K961941 BIO-RAD 3726 EAST MIRALOMA AVE.
ANAHEIM CA 92806
K001373 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K992550 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K022991 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618
K011494 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K012513 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K002460 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K984225 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618
K965171 BIO-RAD 3726 EAST MIRALOMA AVE.
ANAHEIM CA 92806
K971954 BIO-RAD 3726 EAST MIRALOMA AVE.
ANAHEIM CA 92806
K043208 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618
K011867 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618
K992741 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K042324 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K002196 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K971952 BIO-RAD 3726 EAST MIRALOMA AVE.
ANAHEIM CA 92806
K981532 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K984594 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K011579 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K983807 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K992172 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K984477 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618
K990888 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618
K050536 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K033387 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618
K042815 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K150300 Bio-Rad Laboratories 9500 Jeronimo Road
Irvine CA 92618-2017
K140916 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K123198 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K132227 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K130761 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K140764 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K143379 Bio-Rad Laboratories 9500 Jeronimo Road
Irvine CA 92618
K123775 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K071675 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K141073 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K163015 BIO-RAD LABORATORIES 9500 JERONIMO ROAD
IRVINE CA 92618-2017
K122838 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K130162 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K123663 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K134013 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K082036 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K133960 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K073080 Bio-Rad Laboratories 9500 JERONIMO RD.
IRVINE CA 92618-2017
K042335 BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD.
IRVINE CA 92618-2017
K040277 BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD.
IRVINE CA 92618-2017
K130963 BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD.
IRVINE CA 92618-2017
K043108 BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD.
IRVINE CA 92618-2017
K040822 BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD.
IRVINE CA 92618-2017
K020817 BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD.
IRVINE CA 92618-2017
K040273 BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD.
IRVINE CA 92618-2017
K022041 BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD.
IRVINE CA 92618-2017
K072835 BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD.
IRVINE CA 92618-2017
K121794 BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD.
IRVINE CA 92618-2017
K100727 BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD.
IRVINE CA 92618-2017
K963770 BIOCIRCUITS CORP. 1324 CHESAPEAKE TERR.
SUNNYVALE CA 94089
K012431 BIONOSTICS, INC. 2 CRAIG RD.
ACTON MA 01720
K021930 BIONOSTICS, INC. 7 JACKSON RD.
DEVENS MA 01432
K980178 BIONOSTICS, INC. 2 CRAIG RD.
ACTON MA 01720
K032453 BIONOSTICS, INC. 7 JACKSON RD.
DEVENS MA 01432
K972868 BIONOSTICS, INC. 2 CRAIG RD.
ACTON MA 01720
K961359 BIOPROCESSING, INC. 18 MUSSEY RD.
SCARBOROUGH ME 04074
K060850 BIORESOURCE TECHNOLOGY, INC. 575 Shirlynn Court
Los Altos CA 94022
K040352 BIORESOURCE TECHNOLOGY, INC. 1531 N.W. 65TH AVE.
FORT LAUDERDALE FL 33313-4542
K030088 BIOSITE INCORPORATED 11030 ROSELLE ST.
SAN DIEGO CA 92121
K030089 BIOSITE INCORPORATED 11030 ROSELLE ST.
SAN DIEGO CA 92121
K040459 BIOSITE INCORPORATED 11030 ROSELLE ST.
SAN DIEGO CA 92121
K093032 BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD
SAN DIEGO CA 92121
K072892 BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD
SAN DIEGO CA 92121
K974827 BIOSITE INCORPORATED 11030 ROSELLE ST.
SAN DIEGO CA 92121
K974613 BLACKHAWK BIOSYSTEMS, INC. 12945 ALCOSTA BLVD.
SAN RAMON CA 94583
K974826 BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0457
K983492 BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0457
K981401 BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0457
K974384 BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR.
PLEASANTON CA 94588-2722
K983166 BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0457
K970147 BOEHRINGER MANNHEIM CORP. 2400 BISSO LN.
CONCORD CA 94524-4117
K984372 BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0457
K984419 BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0457
K962575 BOEHRINGER MANNHEIM CORP. 2400 BISSO LN.
CONCORD CA 94524
K972235 BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0457
K973629 BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR.
PLEASANTON CA 94588-2722
K972048 BOSTON BIOMEDICA, INC. 375 WEST ST.
WEST BRIDGEWATER MA 02379
K972307 BOSTON BIOMEDICA, INC. 375 WEST ST.
WEST BRIDGEWATER MA 02379
K971406 BOSTON BIOMEDICA, INC. 375 WEST ST.
WEST BRIDGEWATER MA 02379
K971657 BOSTON BIOMEDICA, INC. 375 WEST ST.
WEST BRIDGEWATER MA 02379
K964640 CANYON DIAGNOSTICS, INC. 4075 LEAVERTON COURT
ANAHEIM CA 92807
K962630 CASCO STANDARDS P.O BOX 970
YARMOUTH ME 04096
K961750 CASCO STANDARDS P.O BOX 970
YARMOUTH ME 04096
K972904 CASCO STANDARDS P.O BOX 970
YARMOUTH ME 04096
K002174 CASCO-NERL DIAGNOSTICS CORPORATION (MAINE) 500 RIVERSIDE INDUSTRIAL PKWY.
PORTLAND ME 04103
K992034 CASCO-NERL DIAGNOSTICS CORPORATION (MAINE) 500 RIVERSIDE INDUSTRIAL PKWY.
PORTLAND ME 04103
K993014 CASCO-NERL DIAGNOSTICS CORPORATION (MAINE) 500 RIVERSIDE INDUSTRIAL PKWY.
PORTLAND ME 04103
K970956 CHIRON DIAGNOSTICS CORP. 63 NORTH ST.
MEDFIELD MA 02052
K970979 CHIRON DIAGNOSTICS CORP. 17392 DAIMLER ST.
IRVINE CA 92614
K971071 CHIRON DIAGNOSTICS CORP. 17392 DAIMLER ST.
IRVINE CA 92614
K971405 CHIRON DIAGNOSTICS CORP. 17392 DAIMLER ST.
IRVINE CA 92614
K012855 CLINICAL CONTROLS DIVISION 12038 CENTRALIA AVE.
HAWAIIAN GARDENS CA 90716
K955690 CLINICAL CONTROLS, INC. 750 FARROLL RD.
GROVER BEACH CA 93433
K955691 CLINICAL CONTROLS, INC. 750 FARROLL RD.
GROVER BEACH CA 93433
K080973 CLINIQA CORPORATION 774 N. TWIN OAKS VALLEY RD.
SAN MARCOS CA 92069
K062916 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K061182 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K030705 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K070741 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K082107 CLINIQA CORPORATION 288 DISTRIBUTION STREET
SAN MARCOS CA 92078
K083554 CLINIQA CORPORATION 288 DISTRIBUTION STREET
SAN MARCOS CA 92078
K031921 CLINIQA CORPORATION 1432-B SOUTH MISSION RD.
FALLBROOK CA 92028
K033162 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K040535 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K032074 CLINIQA CORPORATION 1432-B SOUTH MISSION RD.
FALLBROOK CA 92028
K040091 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K022936 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K031577 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K031575 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K023250 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K022867 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K030566 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K022885 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K030150 CLINIQA CORPORATION 1432-B SOUTH MISSION RD.
FALLBROOK CA 92028
K013332 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K023661 CLINIQA CORPORATION 1432 SOUTH MISSION RD.
FALLBROOK CA 92028
K062593 COMPASS BIOSCIENCE 1850 EVERGREEN ST.
DUARTE CA 91010-2906
K121759 CONE BIOPRODUCTS 1012 N Austin St
SEGUIN TX 78155
K001249 CONSOLIDATED TECHNOLOGIES OF WISCONSIN 2170 WOODWARD ST.
AUSTIN TX 78744-1832
K000810 CONSOLIDATED TECHNOLOGIES OF WISCONSIN 2170 WOODWARD ST.
AUSTIN TX 78744-1832
K972080 CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100
AUSTIN TX 78744-1832
K000116 CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100
AUSTIN TX 78744-1832
K961912 CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100
AUSTIN TX 78744-1832
K981339 CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100
AUSTIN TX 78744-1832
K961293 CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100
AUSTIN TX 78744-1832
K973469 CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100
AUSTIN TX 78744-1832
K963346 CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100
AUSTIN TX 78744-1832
K003716 CONSOLIDATED TECHNOLOGY 4401 FREIDRICH LN. BLDG 1
AUSTIN TX 78744-1832
K020237 CONSOLIDATED TECHNOLOGY 4401 FREIDRICH LN. BLDG 1
AUSTIN TX 78744-1832
K033344 CONSOLIDATED TECHNOLOGY 4401 FREIDRICH LN. BLDG 1
AUSTIN TX 78744-1832
K023731 CONSOLIDATED TECHNOLOGY 4401 FREIDRICH LN. BLDG 1
AUSTIN TX 78744-1832
K993310 DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY;
P.O. BOX 6101, NEWARK DE 19714-6101
K071980 DADE BEHRING, INC. P.O. BOX 6101
NEWARK, DE 19714
K991182 DADE BEHRING, INC. P.O. BOX 6101
NEWARK DE 19714-6101
K012468 DADE BEHRING, INC. GLASGOW SITE
NEWARK DE 19714-6101
K021381 DADE BEHRING, INC. 514 GBC DR.
NEWARK DE 19702
K032237 DADE BEHRING, INC. GLASGOW SITE
NEWARK DE 19714-6101
K991704 DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY;
P.O. BOX 6101, NEWARK DE 19714-6101
K002852 DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY;
P.O. BOX 6101, NEWARK DE 19714-6101
K982637 DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST.
LOS ANGELES CA 90045-5597
K981455 DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST.
LOS ANGELES CA 90045-5597
K965114 DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST.
LOS ANGELES CA 90045-5597
K982473 DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST.
LOS ANGELES CA 90045-5597
K103364 DIAMOND DIAGNOSTICS, INC 333 Fiske St
Holliston MA 01746
K093492 DIAMOND DIAGNOSTICS, INC. 333 FISKE ST.
HOLLISTON MA 01746
K124009 DIAMOND DIAGNOSTICS, INC. 333 FISKE ST.
HOLLISTON MA 01746
K060206 DIAMOND DIAGNOSTICS, INC. 333 FISKE ST.
HOLLISTON MA 01746
K062674 DIAMOND DIAGNOSTICS, INC. 333 FISKE ST.
HOLLISTON MA 01746
K093384 DIAMOND DIAGNOSTICS, INC. 333 FISKE ST.
HOLLISTON MA 01746
K111996 ELITECHGROUP 21720 23RD DR SE
BOTHELL WA 98021
K131595 EUROTROL B.V. KEPLERLAAN 20
EDE NL 6716 BS
K121468 EUROTROL B.V. KEPLERLAAN 20
EDE 6716 BS
K101809 FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY
MALVERN PA 19355-1307
K131479 HELENA LABORATORIES 1530 LINDBERGH DR.
BEAUMONT TX 77704
K031101 HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD.
COLUMBIA MD 21045
K012243 HEMATRONIX, INC. 524 STONE RD.
BENICIA CA 94510
K133676 HORIBA ABX SAS PARC EUROMEDECINE
MONTPELLIER 34184
K011169 INTERNATIONAL ENZYMES, INC. 1432-B SOUTH MISSION RD.
FALLBROOK CA 92028
K965048 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR.
ROCHESTER NY 14650-0882
K973517 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR.
ROCHESTER NY 14650-0882
K973030 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR.
ROCHESTER NY 14650-0882
K983241 KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR.
SEATTLE WA 98188-3412
K983130 KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR.
SEATTLE WA 98188-3412
K082067 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K103271 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K053247 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K012117 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K023410 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K012118 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K012119 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K012120 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K013265 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K020450 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K023352 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K090475 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K091225 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K041975 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K072246 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K083891 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K050504 MAINE STANDARDS CO. 765 ROOSEVELT TRAIL
WINDHAM ME 04062-5365
K110880 MAINE STANDARDS COMPANY, LLC 765 ROOSEVELT TRAIL
WINDHAM ME 04062
K142964 MAINE STANDARDS COMPANY, LLC 221 US Route 1
Cumberland Foreside ME 04110
K970976 MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD.
CAMARILLO CA 93012-8058
K010111 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K980514 MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD.
CAMARILLO CA 93012-8058
K011548 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K001758 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K960824 MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD.
CAMARILLO CA 93012-8058
K960862 MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD.
CAMARILLO CA 93012-8058
K032335 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K040880 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K023669 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K031364 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K030942 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K013734 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K030679 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K023867 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K013995 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K011731 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K993546 MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK
CAMARILLO CA 93012
K061196 MICROGENICS CORP. 46360 FREMONT BLVD.
FREMONT CA 94538
K041073 MICROGENICS CORP. 46360 FREMONT BLVD.
FREMONT CA 94538
K092051 MICROGENICS CORP. 46360 FREMONT BLVD
FREMONT CA 94538
K110616 MICROGENICS CORP. 46360 FREMONT BLVD
FREMONT CA 94538
K122291 Microgenics Corporation 46360 FREMONT BLVD
FREMONT CA 94538-6406
K110738 Microgenics Corporation 46360 FREMONT BLVD.
FREMONT CA 94538
K050125 MORE DIAGNOSTICS 2020 11TH ST.
LOS OSOS CA 93402
K972070 NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY
SAN JUAN CAPISTRANO CA 92690-6130
K962997 NOVA BIOMEDICAL CORP. 200 PROSPECT ST.
WALTHAM MA 02454-9141
K962982 NOVA BIOMEDICAL CORP. 200 PROSPECT ST.
WALTHAM MA 02454-9141
K955264 NOVA BIOMEDICAL CORP. 200 PROSPECT ST.
WALTHAM MA 02454-9141
K955252 NOVA BIOMEDICAL CORP. 200 PROSPECT ST.
WALTHAM MA 02454-9141
K955260 NOVA BIOMEDICAL CORP. 200 PROSPECT ST.
WALTHAM MA 02454-9141
K101633 NOVA BIOMEDICAL CORP. 200 PROSPECT ST.
WALTHAM MA 02454-9141
K042625 ORION DIAGNOSTICA OY KOIVU MANKKAAN TIE 6
ESPOO 02200
K990016 Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR.
ROCHESTER NY 14626-5101
K990531 Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR.
ROCHESTER NY 14626-5101
K983513 Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR.
ROCHESTER NY 14626-5101
K983507 Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR.
ROCHESTER NY 14626-5101
K992349 Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR.
ROCHESTER NY 14626-5101
K070504 POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE
CANTON MI 48188
K022401 POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD.
INDIANAPOLIS IN 46268
K123725 Qualigen, Inc. 2042 CORTE DEL NOGAL
CARLSBAD CA 92011
K973894 QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD.
REDONDO BEACH CA 90278-1205
K970862 QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD.
REDONDO BEACH CA 90278-1205
K022851 QUIDEL CORP. 10165 MCKELLAR CT.
SAN DIEGO CA 92121
K153712 RADIOMETER AMERICA INC. 250 S. KRAEMER BLVD
BREA CA 92821
K051928 RADIOMETER MEDICAL APS AKANDEVEJ 21
BRONSHOJ DK-2700
K140971 RANDOX LABORATORIES LIMITED 55 DIAMOND RD.
CRUMLIN, CO.ANTRIM BT29 4QY
K140393 RANDOX LABORATORIES LIMITED 55 DIAMOND RD.
CRUMLIN, CO.ANTRIM BT29 4QY
K140522 RANDOX LABORATORIES LIMITED 55 DIAMOND RD.
CRUMLIN, CO.ANTRIM BT29 4QY
K110534 RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD CRUMLIN
CRUMLIN ANTRIM BT29 4QY
K130337 RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD
CRUMLIN, ANTRIM BT29 4QY
K041361 RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD CRUMLIN
CRUMLIN BT29 4QY
K972608 RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD
CRUMLIN BT29 4QY
K132156 RANDOX LABORATORIES, LTD. 55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY
K040379 RANDOX LABORATORIES, LTD. 55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY
K121603 RANDOX LABORATORIES, LTD. 55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY
K022591 RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD
CRUMLIN, CO. ANTRIM BT29 4QY
K112337 RANDOX LABORATORIES, LTD. 55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY
K110904 RANDOX LABORATORIES, LTD. 55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY
K113720 RANDOX LABORATORIES, LTD. 55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY
K972214 ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP
SOMERVILLE NJ 08876-3771
K102157 Roche Diagnostics 9115 HAGUE ROAD
INDIANAPOLIS IN 46250-0416
K092320 Roche Diagnostics 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0416
K090541 Roche Diagnostics 9115 HAGUE ROAD
INDIANAPOLIS IN 46250
K111506 Roche Diagnostics 9115 HAGUE ROAD
INDIANAPOLIS IN 46250-0416
K102016 Roche Diagnostics 9115 Hague Road
Indianapolis IN 46250
K062379 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K051185 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K000270 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0457
K051517 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K051543 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0457
K033937 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K051687 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K042389 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K041812 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K041227 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0457
K040280 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K992900 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0457
K993360 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250-0457
K032089 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K050387 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K060429 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K070200 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K973791 SC CALIBRATORS & CONTROLS LLC. 1701 BERKELEY ST.
SANTA MONICA CA 90404
K973790 SC CALIBRATORS & CONTROLS LLC. 1701 BERKELEY ST.
SANTA MONICA CA 90404
K954247 SCANTIBODIES LABORATORY, INC. 9251 S.W. 52ND TERRACE
MIAMI FL 33165
K955812 SCANTIBODIES LABORATORY, INC. 9251 S.W. 52ND TERRACE
MIAMI FL 33165
K101863 SEBIA 1705 CORPORATE DRIVE
NORCROSS GA 30093
K040925 SEBIA 13805 WATERLOO
CHELSEA MI 48118
K992939 SERACARE TECHNOLOGY 2170 WOODWARD ST.
AUSTIN TX 78744-1832
K992770 SERACARE TECHNOLOGY 2170 WOODWARD ST.
AUSTIN TX 78744-1832
K993631 SERACARE TECHNOLOGY 2170 WOODWARD ST.
AUSTIN TX 78744-1832
K071433 SPECIALTY MEDICAL SUPPLIES 940 CROSSROADS BLVD.
SEGUIN TX 78155
K981474 SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL
TORONTO, ONTARIO M9C1C2
K991447 SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL
TORONTO, ONTARIO M9C1C2
K961195 STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD.
OMAHA NE 68144
K982290 STRECK LABORATORIES, INC. 14124 INDUSTRIAL RD.
OMAHA NE 68145-0625
K162530 TECHNO-PATH MANUFACTURING BALLINA
CO. TIPPERARY
K132091 TECHNO-PATH MANUFACTURING LTD. 325 BIG ELM ST.
HIGHLAND VILLAGE TX 75077
K131992 TECHNO-PATH MANUFACTURING LTD. 325 BIG ELM ST.
HIGHLAND VILLAGE TX 75077
K132751 TECHNO-PATH MANUFACTURING LTD. 325 BIG ELM ST.
HIGHLAND VILLAGE TX 75077
K131993 TECHNO-PATH MANUFACTURING LTD. 325 BIG ELM ST.
HIGHLAND VILLAGE TX 75077
K981915 THE BINDING SITE, LTD. EAST TOWER, SUITE 600
SANTA MONICA CA 90404
K052056 THERMO-ELECTRON CORP. 189-199 BROWNS RD.
NOBLE PARK, VICTORIA 3174
K111063 VITAL DIAGNOSTICS (MANUFACTURING) PTY. LTD. 189-190 BROWNS ROAD
NOBLE PARK VICTORIA 3174
K030482 WIENER LABORATORIES 2944 RIOBAMBA
ROSARIO 2000




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