FDA 510(k) Applications for Medical Device:
Assay, Glycosylated Hemoglobin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K991246 | A.P. TOTAL CARE, INC. |
70 HAWLEY AVE, | BRIDGEPORT | CT | |
| K214117 | Abbott Diagnostics Technologies AS |
Kjelsasveien 161 | Oslo | NO-0884 | |
| K991483 | ABBOTT LABORATORIES |
200 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064 |
| K992085 | ABBOTT LABORATORIES |
DEPT 9YC, BIDG. AP31 | ABBOTT PARK | IL | 60064-6200 |
| K171650 | Abbott Rapid Diagnostics |
9975 Summers Ridge Road | San Diego | CA | 92121 |
| K151809 | Alere Technologies AS |
KJELSAASVEIEN 161 | OSLO | NO-0884 | |
| K113437 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K091711 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K170623 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC |
4 Henderson Drive | West Caldwell | NJ | 07006 |
| K063306 | ALFA WASSERMANN, INC. |
4 HENDERSON DR. | WEST CALDWELL | NJ | 07006 |
| K030553 | ARKRAY, INC. |
2320 SCIENTIFIC PARK DR. | WILMINGTON | NC | 28405 |
| K170147 | ASAHI KASEI PHARMA CORPORATION |
1-105 KANDA JINBOCHO | TOKYO | 101-8101 | |
| K121842 | AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE, SCOTLAND | DD2 1XA | |
| K072686 | AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE, SCOTLAND | DD2 1XA | |
| K110056 | AXIS-SHIELD POC AS |
P.O. BOX 6863 | OSLO | N-0504 | |
| K050574 | AXIS-SHIELD POC AS |
P.O. BOX 262069 | SAN DIEGO | CA | 92196 |
| K955087 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K090413 | BAYER HEALTHCARE, LLC |
510 OAKMEAD PKWY. | SUNNYVALE | CA | 94085 |
| K120199 | BECKMAN COULTER, INC |
250 S. KRAEMER BLVD | BREA | CA | 92821 |
| K042459 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K010748 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 | BREA | CA | 92822 |
| K140829 | BECKMAN COULTER, INC. |
250 S. KRAEMER BLVD. | BREA | CA | 92821 |
| K121492 | BECKMAN COULTER, INC. |
250 SOUTH KRAEMER BLVD | BREA | CA | 92822 |
| K973696 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K984268 | BIO-RAD |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547-1803 |
| K003280 | BIO-RAD |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547-1803 |
| K063643 | BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547 |
| K070819 | BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547 |
| K041444 | BIO-RAD LABORATORIES, INC. |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547 |
| K031043 | BIO-RAD LABORATORIES, INC. |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547 |
| K060001 | BIO-RAD LABORATORIES, INC. |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547 |
| K040872 | BIO-RAD LABORATORIES, INC. |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547 |
| K070452 | BIO-RAD LABORATORIES, INC. |
4000 ALFRED NOBEL DR | HERCULES | CA | 94547 |
| K090699 | BIO-RAD LABORATORIES, INC. |
4000 ALFRED NOBEL DR | HERCULES | CA | 94547 |
| K063400 | BIO-RAD LABORATORIES, INC. |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547 |
| K140801 | BIO-RAD LABORATORIES, INC. |
4000 ALFRED NOBEL DR. | HERCULES | CA | 94547 |
| K130860 | BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS |
4000 ALFRED NOBEL DRIVE | HERCULES | CA | 94547 |
| K122472 | BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS |
4000 ALFRED NOBEL DRIVE | HERCULES | CA | 94547 |
| K130990 | BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS |
4000 ALFRED NOBEL DRIVE | HERCULES | CA | 94547 |
| K031296 | BIODIAGNOSTIC INTL |
615 NORTH BERRY ST. | BREA | CA | 92821 |
| K161533 | BioHermes Co., Ltd |
2F, 3F, No 136 Mashan Meiliang Road, | Wuxi | JS510 | |
| K991850 | BIOSAFE LABORATORIES, INC. |
300 KNIGHTSBRIDGE PKWY., #150 | LINCOLNSHIRE | IL | 60069 |
| K974491 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K021484 | CANTERBURY SCIENTIFIC LTD. |
21 WROXTON TERRACE | CHRISTCHURCH | ||
| K111128 | CERAGEM INTERNATIONAL, INC. |
3699 WILSHIRE BLVD.,SUITE 930 | LOS ANGELES | CA | 90010 |
| K031042 | CLINICAL DATA, INC. |
1075 WEST LAMBERT ROAD | BREA | CA | 92821-2944 |
| K011852 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY | NEWARK | DE | 19714 |
| K013465 | DIABETES TECHNOLOGIES, INC. |
216 WEST JACKSON ST. | THOMASVILLE | GA | 31792 |
| K983172 | DIABETES TECHNOLOGIES, INC. (DTI) |
216 WEST JACKSON ST. | THOMASVILLE | GA | 31792 |
| K160762 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K110188 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K042193 | DIAZYME LABORATORIES |
3550 GENERAL ATOMICS CT. | SAN DIEGO | CA | 92121 |
| K133803 | DIAZYME LABORATORIES |
12889 GREGG COURT | POWAY | CA | 92064 |
| K070734 | DIAZYME LABORATORIES |
3550 GENERAL ATOMICS CT. | SAN DIEGO | CA | 92121 |
| K183230 | Drawbridge Health, Inc. |
11535 Sorrrento Valley Road, Suite 407 | San Diego | CA | 92121 |
| K180509 | EKF-diagnostic GmbH |
Ebendorfer Chaussee 3 | Barleben | 30179 | |
| K980888 | EXOCELL, INC. |
3508 MARKET ST., SUITE 420 | PHILADELPHIA | PA | 19104 |
| K973365 | EXPRESS-MED, INC. |
3592 CORPORATE DR. | COLUMBUS | OH | 43231 |
| K971919 | FLEXSITE DIAGNOSTICS, INC. |
1900 K STREET, N.W. | WASHINGTON | DC | 20006-1108 |
| K050178 | GENERAL ATOMICS |
3550 GENERAL ATOMICS COURT | SAN DIEGO | CA | 92121 |
| K000239 | GENZYME CORP. |
500 KENDALL STREET | CAMBRIDGE | MA | 02142-1562 |
| K983726 | GENZYME CORP. |
500 KENDALL STREET | CAMBRIDGE | MA | 02142-1562 |
| K141944 | HOME ACCESS HEALTH CORP. |
62 FOREST STREET SUITE 300 | MARLBOROUGH | MA | 01752 |
| K073309 | HORIBA ABX |
PARC EUROMEDECINE | MONTPELLIER | 34184 | |
| K082275 | INFOPIA CO., LTD |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K121366 | INFOPIA CO., LTD |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K141750 | INFOPIA CO., LTD |
2651 E CHAPMAN AVE STE 110 | FULLERTON | CA | 92833 |
| K192369 | iXensor Co. Ltd. |
6F., No.9, Aly. 2, Ln. 35, Jihu Road. Neihu Dist. | Taipei City | 114 | |
| K181915 | iXensor Co., LTD. |
6F., No.9 Aly. 2, Ln. 35, Jihu Road. Neihu Dist. | Taipei | 114 | |
| K192987 | Jana Care, Inc |
8 Saint Mary's St, Suite 936 | Boston | MA | 02215 |
| K080618 | JAS Diagnostics, Inc. |
7220 NW 58TH ST. | MIAMI | FL | 33166 |
| K962597 | LXN CORP. |
5830 OBERLIN DR. | SAN DIEGO | CA | 92121 |
| K081269 | MEC DYNAMICS CORP |
2225 MARTIN AVE | SANTA CLARA | CA | 95050 |
| K093548 | MEC DYNAMICS CORP |
90 ROSE ORCHARD WAY | SAN JOSE | CA | 95134 |
| K091400 | MEC DYNAMICS CORP |
2225 MARTIN AVE | SANTA CLARA | CA | 95050 |
| K120497 | MEDICA CORP. |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K983253 | MEDISENSE, INC. |
4-A CROSBY DR. | BEDFORD | MA | 01730-1402 |
| K033847 | METRIKA, INC. |
510 OAKMEAD PKWY. | SUNNYVALE | CA | 94085-4022 |
| K022661 | METRIKA, INC. |
510 OAKMEAD PKWY. | SUNNYVALE | CA | 94085-4022 |
| K020235 | METRIKA, INC. |
510 OAKMEAD PKWY. | SUNNYVALE | CA | 94085-4022 |
| K020234 | METRIKA, INC. |
510 OAKMEAD PKWY. | SUNNYVALE | CA | 94085-4022 |
| K000887 | METRIKA, INC. |
510 OAKMEAD PKWY. | SUNNYVALE | CA | 94085-4022 |
| K000885 | METRIKA, INC. |
510 OAKMEAD PKWY. | SUNNYVALE | CA | 94085-4022 |
| K051321 | METRIKA, INC. |
510 OAKMEAD PKWY. | SUNNYVALE | CA | 94085-4022 |
| K053411 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K963844 | MORAX |
13805 WATERLOO RD. | CHELSEA | MI | 48118 |
| K221326 | Nova Biomedical Corporation |
200 Prospect St. | Waltham | MA | 02454 |
| K031380 | OLYMPUS AMERICA, INC. |
3131 WEST ROYAL LN. | IRVING | TX | 75063-3104 |
| K041764 | ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K060650 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K990899 | OSBORN GROUP, INC. |
14901 WEST 117TH ST. | OLATHE | KS | 66062 |
| K984529 | OSBORN LABORATORIES, INC. |
14901 WEST 117TH ST. | OLATHE | KS | 66062 |
| K993590 | POINTE SCIENTIFIC, INC. |
1025 JOHN A. PAPALAS DR. | LINCOLN PARK | MI | 48146 |
| K031539 | POINTE SCIENTIFIC, INC. |
1025 JOHN A. PAPALAS DR. | LINCOLN PARK | MI | 48146 |
| K023654 | POLYMEDCO, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K020532 | POLYMEDCO, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K062658 | PRIMUS CORP. |
4231 E. 75TH TERRACE | KANSAS CITY | MO | 64132 |
| K994045 | PRIMUS CORP. |
7235 CENTRAL | KANSAS CITY | MO | 64114 |
| K992921 | PRIMUS CORP. |
P.O. BOX 22599 | KANSAS CITY | MO | 64113 |
| K112015 | PRIMUS CORPORATION DBA TRINITY BIOTECH |
4231 E. 75TH TERRACE | KANSAS CITY | MO | 64132 |
| K993131 | PRIMUS, INC. |
4747 TROOST | KANSAS CITY | MO | 64110 |
| K041635 | PROVALIS DIAGNOSTICS LTD. |
16809 BRIARDALE RD. | ROCKVILLE | MD | 20855 |
| K001392 | PROVALIS DIAGNOSTICS LTD. |
16809 BRIARDALE RD. | ROCKVILLE | MD | 20855 |
| K011933 | PROVALIS DIAGNOSTICS LTD. |
16809 BRIARDALE RD. | ROCKVILLE | MD | 20855 |
| K231465 | Qurasense |
3517 Edison Way, Ste. D | Menlo Park | CA | 94025 |
| K023763 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | CRUMLIN, CO. ANTRIM | BT29 4QY | |
| K021897 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | CRUMLIN | BT29 4QY | |
| K102914 | ROCHE |
9115 HAGUE RD | INDIANAPOLIS | IN | 46250 |
| K952337 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K961674 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K110313 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K990992 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K003120 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K052464 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K072714 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K163633 | Roche Diagnostics Operations |
9115 Hague Road | Indianapolis | IN | 46250 |
| K130014 | Sakae Corporation |
575 Shirlynn Court | Los Altos | CA | 94022 |
| K142789 | Sakae Corporation |
239 ONISHI | FUJIOKA, GUNMA | 370-1401 | |
| K140827 | SD Biosensor, Inc. |
C-4th & 5th Floor digital Empire Building 980-3 | Suwon-si | 443-702 | |
| K162281 | SEBIA |
1705 CORPORATE DRIVE | NORCROSS | GA | 30093 |
| K122101 | SEBIA |
1705 CORPORATE DRIVE | DULUTH | GA | 30093 |
| K133344 | SEBIA |
1705 CORPORATE DRIVE | NORCROSS | GA | 30093 |
| K100547 | SEPPIM S.A.S. |
21720 23RD DR SE | BOTHELL | WA | 98021 |
| K033674 | SERADYN INC. |
7998 GEORGETOWN RD. | INDIANAPOLIS | IN | 46268-5260 |
| K110934 | SIEMENS HEALTHCARE DIAGNOSTICS |
333 CONEY STREET | WALPOLE | MA | 02032-1516 |
| K102510 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE | NEWARK | DE | 19714 |
| K131307 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVE | TARRYTOWN | NY | 10591 |
| K102045 | SIEMENS HEATLHCARE DIAGNOSTICS INC |
500 GBC DRIVE | NEWARK | DE | 19714-6101 |
| K081895 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K071466 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
2 EDGEWATER DR. | NORWOOD | MA | 02062 |
| K012410 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K173127 | Skyla Corporation H.S.P.B. |
1f. No. 8, Dusing Rd., Hsinchu Science Park | Hsinchu | 30078 | |
| K142664 | TAIDOC TECHNOLOGY CORPORATION |
B1-7F , No.127, Wugong 2nd Rd., Wugu District | New Taipei City | 24888 | |
| K051200 | TECO DIAGNOSTICS |
1268 NORTH LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
| K012525 | THERMO DMA, INC. |
845 AVE. G EAST | ARLINGTON | TX | 76011 |
| K063209 | THERMO ELECTRON OY |
RATASTIE 2 | VANTAA | 01620 | |
| K071132 | Tosoh BioScience, Inc. |
6000 SHORELINE COURT | SOUTH SAN FRANCISCO | CA | 94080 |
| K100304 | Tosoh BioScience, Inc. |
6000 SHORELINE COURT | SOUTH SAN FRANCISCO | CA | 94080 |
| K972265 | TOSOH MEDICS, INC. |
373 VINTAGE PARK DR. | FOSTER CITY | CA | 94404 |
| K011434 | TOSOH MEDICS, INC. |
347 OYSTER POINT BLVD., | SAN FRANCISCO | CA | 94080 |
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