FDA 510(k) Applications for Medical Device:
Calibrator, Secondary
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K032458 | ABBOTT LABORATORIES |
200 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-6187 |
| K170160 | Abbott Laboratories |
100 Abbott Park Road, Dept 09AA, Bldg. AP08 | Abbott Park | IL | 60064 |
| K111023 | ABBOTT LABORATORIES |
100 ABBOTT PARK ROAD | ABBOTT PARK | IL | 60064 |
| K151566 | ABBOTT LABORATORIES |
100 Abbott Park Road Dept. 09VA, AP08 | Abbott Park | IL | 60064 |
| K053330 | ABBOTT LABORATORIES |
100 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-6095 |
| K021535 | BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K021532 | BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K033643 | BAYER HEALTHCARE, DIAGNOSTICS DIVISION |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K061139 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K141374 | BECKMAN COULTER IRELAND INC |
250 S. KRAEMER BLVD. E1.SE.01 | BREA | CA | 92821 |
| K080166 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K111952 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K061282 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K003098 | BECKMAN COULTER, INC. |
7330 CARROLL RD. | SAN DIEGO | CA | 92196 |
| K012900 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K042651 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K070144 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K142985 | BECKMAN COULTER, INC. |
250 S. KREAMER BOULEVARD | BREA | CA | 92821 |
| K082141 | BIOKIT S.A. |
CAN MALE S/N | BARCELONA | 08186 | |
| K132400 | BIOKIT S.A. |
CAN MALE, S/N | LLISSA D'AMUNT, BARCELONA | 08186 | |
| K964368 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524 |
| K060322 | CLINIQA CORPORATION |
1432-B SOUTH MISSION RD. | FALLBROOK | CA | 92028 |
| K062152 | DADE BEHRING, INC. |
500 GBC DR., M/S 514 | NEWARK | DE | 19714 |
| K983850 | DADE BEHRING, INC. |
BLDG. 500 MAIL BOX 514 | NEWARK | DE | 19714-6101 |
| K020723 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY | NEWARK | DE | 19714-6101 |
| K010314 | DADE BEHRING, INC. |
P.O. BOX 6101, BUILDING 500 | NEWARK | DE | 19714 |
| K010208 | DADE BEHRING, INC. |
GLASCO B500 M.S. 514 | NEWARK | DE | 19714-6101 |
| K990554 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K994291 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K020980 | DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 | NEWARK | DE | 19714 |
| K070552 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714 |
| K053576 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | P.O. BOX 6101, NEWARK | DE | 19714-6101 |
| K061818 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714 |
| K072717 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | NEWARK | DE | 19714-6101 |
| K061702 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714 |
| K061885 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K061751 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K983693 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K984193 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K983548 | DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 | NEWARK | DE | 19714 |
| K991705 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | P.O. BOX 6101, NEWARK | DE | 19714-6101 |
| K003501 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | P.O. BOX 6101, NEWARK | DE | 19714-6101 |
| K991176 | DADE BEHRING, INC. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K982292 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K990824 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K981097 | DADE BEHRING, INC. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K981101 | DADE BEHRING, INC. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K981100 | DADE BEHRING, INC. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K012233 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K983722 | DADE BEHRING, INC. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K060371 | DADE BEHRING, INC. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K963493 | DADE CHEMISTRY SYSTEMS, INC. |
P.O. BOX 6101, GLASGOW GLDG. | NEWARK | DE | 19714-6101 |
| K970336 | DADE CHEMISTRY SYSTEMS, INC. |
P.O. BOX 6101, GLASGOW GLDG. | NEWARK | DE | 19714-6101 |
| K973100 | DADE CHEMISTRY SYSTEMS, INC. |
GLASGOW SITE | NEWARK | DE | 19714-6101 |
| K970389 | DADE CHEMISTRY SYSTEMS, INC. |
RT. 896, GLASCOW BLDG. 500 | GLASGOW | DE | 19702 |
| K962594 | DADE INTL., INC. |
ROUTE 896 | GLASGOW | DE | 19702 |
| K973668 | DADE INTL., INC. |
RT. 896, GLASCOW BLDG. 500 | NEWARK | DE | 19714 |
| K060359 | DENKA SEIKEN CO., LTD. |
1-2-2, MINAMI HON CHO | GOSEN-SHI, NIIGATA | 959-1695 | |
| K060140 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN, PE | C1E 2A6 | |
| K092937 | DIAGNOSTICA STAGO, INC. |
5 CENTURY DR. | PARSIPPANY | NJ | 07054 |
| K121027 | DIAMOND DIAGNOSTICS, INC |
333 Fiske St | Holliston | MA | 01746 |
| K133751 | DIAMOND DIAGNOSTICS, INC |
333 Fiske St | Holliston | MA | 01746 |
| K120591 | DIAMOND DIAGNOSTICS, INC |
333 Fiske St | Holliston | MA | 01746 |
| K031159 | DIAMOND DIAGNOSTICS, INC. |
331 FISKE ST. | HOLLISTON | MA | 01746 |
| K033060 | DIAMOND DIAGNOSTICS, INC. |
331 FISKE ST. | HOLLISTON | MA | 01746 |
| K020596 | DIAMOND DIAGNOSTICS, INC. |
331 FISKE ST. | HOLLISTON | MA | 01746 |
| K093357 | DIAMOND DIAGNOSTICS, INC. |
333 FISKE ST. | HOLLISTON | MA | 01746 |
| K071039 | DIAMOND DIAGNOSTICS, INC. |
333 FISKE ST. | HOLLISTON | MA | 01746 |
| K013850 | DIAMOND DIAGNOSTICS, INC. |
331 FISKE ST. | HOLLISTON | MA | 01746 |
| K102638 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K131556 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K043378 | DREW SCIENTIFIC LTD. |
SOWERBY WOODS BUSINESS PARK | BARROW IN FURNESS CUMBRIA | LA14 4QR | |
| K122177 | ELITECHGROUP |
21720 23RD DR SE | BOTHELL | WA | 98021 |
| K163521 | FUJIREBIO DIAGNOSTICS, INC |
201 GREAT VALLEY PARKWAY | MALVERN | PA | 19355 |
| K163053 | Fujirebio Diagnostics, Inc. |
201 Great Valley Parkway | Malvern | PA | 19355 |
| K163534 | Fujirebio Diagnostics, Inc. |
201 Great Valley Parkway | Malvern | PA | 19355 |
| K163546 | Fujirebio Diagnostics, Inc. |
201 Great Valley Parkway | Malvern | PA | 19355 |
| K163544 | FUJIREBIO DIAGNOSTICS, INC. |
201 GREAT VALLEY PARKWAY | MALVERN | PA | 19355 |
| K993132 | GENZYME CORP. |
500 KENDALL STREET | CAMBRIDGE | MA | 02142-1562 |
| K011126 | HEMAGEN DIAGNOSTICS, INC. |
9033 RED BRANCH RD. | COLUMBIA | MD | 21045 |
| K060854 | HORIBA ABX |
PARC EUROMEDECINE | MONTPELLIER, HERAULT | 34184 | |
| K092570 | HORIBA ABX SAS |
PARC EUROMEDECINE | MONTPELLIER | 34184 | |
| K033786 | IBL GMBH |
150 CHERRY LANE RD. | EAST STROUDSBURG | PA | 18301 |
| K020454 | JAS Diagnostics, Inc. |
7220 NW 58TH ST. | MIAMI | FL | 33166 |
| K022027 | MISSION DIAGNOSTICS |
331 FISKE ST. | HOLLISTON | MA | 01746 |
| K020894 | MISSION DIAGNOSTICS |
331 FISKE ST. | HOLLISTON | MA | 01746 |
| K130628 | MITSUBISHI CHEMICAL MEDIENCE CORPORATION |
2 BETHESDA METRO CENTER | BETHESDA | MD | 20814 |
| K130603 | MITSUBISHI CHEMICAL MEDIENCE CORPORATION |
2 BETHESDA METRO CENTER | BETHESDA | MD | 20814 |
| K012367 | NICHOLS INSTITUTE DIAGNOSTICS |
33047 CALLE AVIADOR | SAN JUAN CAPISTRANO | CA | 92675 |
| K040692 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K042406 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K040471 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K032285 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K981854 | OLYMPUS DIAGNOSTICA GMBH |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747 |
| K171168 | Ortho Clinical Diagnostics |
100 Indigo Creek Drive | Rochester | NY | 14626 |
| K031924 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K042521 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K042838 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K003096 | Qualigen, Inc. |
2042 CORTE DEL NOGAL | CARLSBAD | CA | 92009 |
| K022533 | Qualigen, Inc. |
2042 CORTE DEL NOGAL | CARLSBAD | CA | 92009 |
| K142181 | RANDOX LABORATORIES LIMITED |
55 DIAMOND RD. | CRUMLIN, CO.ANTRIM | BT29 4QY | |
| K000783 | REFERENCE DIAGNOSTICS, INC. |
23 CROSBY DR. | BEDFORD | MA | 01730 |
| K053291 | REFERENCE DIAGNOSTICS, INC. |
19 CROSBY DR. SUITE 30 | BEDFORD | MA | 01730 |
| K030772 | REFERENCE DIAGNOSTICS, INC. |
19 CROSBY DR. SUITE 30 | BEDFORD | MA | 01730 |
| K021607 | REFERENCE DIAGNOSTICS, INC. |
19 CROSBY DR. SUITE 30 | BEDFORD | MA | 01730 |
| K052148 | REFERENCE DIAGNOSTICS, INC. |
19 CROSBY DR. SUITE 30 | BEDFORD | MA | 01730 |
| K140112 | Roche Diagnostics |
9155 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K170938 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K142021 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K152526 | ROCHE DIAGNOSTICS |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250 |
| K143342 | Roche Diagnostics |
9115 Hague Road, PO Box 50416 | Indanapolis | IL | 46250-0416 |
| K103221 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K052193 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46256 |
| K052982 | Roche Diagnostics |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46250-0416 |
| K050231 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K992981 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K042490 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K003409 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K031299 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K003411 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K060754 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K052002 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K012399 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K043095 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K051012 | SALIMETRICS LLC. |
101 INNOVATION BLVD. SUITE 302 | STATE COLLEGE | PA | 16803-6605 |
| K163078 | SEKISUI DIAGNOSTICS P.E.I. INC. |
70 WATTS AVENUE | CHARLOTTETOWN | C1E 2B9 | |
| K141728 | SENTINEL CH. SpA |
Via Robert Koch, 2 | Milano | 20152 | |
| K042307 | SERADYN INC. |
7998 GEORGETOWN RD. | INDIANAPOLIS | IN | 46268-5260 |
| K103360 | SIEMENS CORP. |
500 GBC DRIVE MAILSTOP 514 | NEWARK | DE | 19714 |
| K162538 | SIEMENS HEALTHCARE DIAGNOSTICS |
333 CONEY STREET | E. WALPOLE | MA | 02032 |
| K110169 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE | NEWARK | DE | 19702 |
| K130698 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE | NEWARK | DE | 19702 |
| K083462 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE M/S 514 | NEWARK | DE | 19714 |
| K081683 | SIEMENS HEALTHCARE DIAGNOSTICS |
MS 514, PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K082680 | SIEMENS HEALTHCARE DIAGNOSTICS |
MS 514, PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K103836 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
500 GBC DRIVE | NEWARK | DE | 19714-6101 |
| K103548 | Siemens Healthcare Diagnostics Inc. |
333 CONEY STREET | EAST WALPOLE | MA | 02032 |
| K081789 | Siemens Healthcare Diagnostics Inc. |
500 GBC DRIVE | NEWARK | DE | 19714-6101 |
| K081319 | Siemens Healthcare Diagnostics Inc. |
500 GBC DRIVE | NEWARK | DE | 19702 |
| K113373 | Siemens Healthcare Diagnostics Inc. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K100293 | SIEMENS HEATLHCARE DIAGNOSTICS INC |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K954326 | SOLARCARE TECHNOLOGIES CORP,INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K062521 | THERMO-ELECTRON CORP. |
189-199 BROWNS RD. | NOBLE PARK, VICTORIA | 3174 | |
| K140648 | Tosoh BioScience, Inc. |
6000 SHORELINE COURT | SOUTH SAN FRANCISCO | CA | 94080 |
| K111762 | Tosoh BioScience, Inc. |
6000 SHORELINE COURT | SOUTH SAN FRANCISCO | CA | 94080 |
| K160113 | TOSOH BIOSCIENCE, INC. |
6000 SHORELINE COURT | SOUTH SAN FRANCISCO | CA | 94080 |
| K143144 | Tosoh BioScience, Inc. |
6000 Shoreline Court, Ste. 101 | South San Francisco | CA | 94080 |
| K153417 | TOSOH BIOSCIENCE, INC. |
6000 SHORELINE COURT | SOUTH SAN FRANCISCO | CA | 94080 |
| K033860 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K040226 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K010332 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K010334 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
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