FDA 510(k) Applications for Medical Device:
System, Test, Thyroid Autoantibody
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K011415 | AMERICAN LABORATORY PRODUCTS CO., LTD. |
P.O. BOX 451 | WINDHAM | NH | 03087 |
| K011201 | AMERICAN LABORATORY PRODUCTS CO., LTD. |
P.O. BOX 451 | WINDHAM | NH | 03087 |
| K972190 | AMERICAN LABORATORY PRODUCTS CO., LTD. |
P.O. BOX 451 | WINDHAM | NH | 03087 |
| K020349 | AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE, SCOTLAND | DD2 1XA | |
| K020348 | AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE, SCOTLAND | DD2 1XA | |
| K020687 | AXIS-SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE, SCOTLAND | DD2 1XA | |
| K012777 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K003291 | BAYER DIAGNOSTICS CORP. |
63 NORTH ST. | MEDFIELD | MA | 02052 |
| K213517 | Beckman Coulter, Inc. |
1000 Lake Hazeltine Dr | Chaska | MN | 55318 |
| K061382 | BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. | CHASKA | MN | 55318-1084 |
| K061794 | BIOMEDICAL DIAGNOSTICS (BMD) SA |
ACTIPOLE 25 | MARNE LA VALLEE CEDEX 2 | 77435 | |
| K992790 | BRAHMS DIAGNOSTICA, LLC. |
29 SOUTH PEACHTREE ST. | NORCROSS | GA | 30071 |
| K992791 | BRAHMS DIAGNOSTICA, LLC. |
29 SOUTH PEACHTREE ST. | NORCROSS | GA | 30071 |
| K000286 | BRAHMS DIAGNOSTICA, LLC. |
29 SOUTH PEACHTREE ST. | NORCROSS | GA | 30071 |
| K000287 | BRAHMS DIAGNOSTICA, LLC. |
29 SOUTH PEACHTREE ST. | NORCROSS | GA | 30071 |
| K033454 | BRAHMS DIAGNOSTICA, LLC. |
35-B SOUTH PEACHTREE ST. | NORCROSS | GA | 30071 |
| K983553 | COLUMBIA BIOSCIENCE, INC. |
8775 M CENTRE PARK DR. | COLUMBIA | MD | 21045 |
| K984228 | COLUMBIA BIOSCIENCE, INC. |
8775 M CENTRE PARK DR. | COLUMBIA | MD | 21045 |
| K092229 | DIAGNOSTIC HYBRIDS, INC. |
1055 EAST STATE STREET | ATHENS | OH | 45701 |
| K083391 | DIAGNOSTIC HYBRIDS, INC. |
1055 EAST STATE STREET | ATHENS | OH | 45701 |
| K991094 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K991096 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K980206 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K963695 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K052308 | FISHER DIAGNOSTICS |
8365 VALLEY PIKE | MIDDLETOWN | VA | 22645-0307 |
| K052407 | FISHER DIAGNOSTICS |
8365 VALLEY PIKE | MIDDLETOWN | VA | 22645-0307 |
| K960370 | IMMCO DIAGNOSTICS, INC. |
963 KENMORE AVE. | BUFFALO | NY | 14223 |
| K960369 | IMMCO DIAGNOSTICS, INC. |
963 KENMORE AVE. | BUFFALO | NY | 14223 |
| K080159 | KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
12554 WEST BRIDGER ST. | BOISE | ID | 83713 |
| K032134 | KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
12554 WEST BRIDGER ST. | BOISE | ID | 83713 |
| K982866 | NICHOLS INSTITUTE DIAGNOSTICS |
33051 CALLE AVIADOR | SAN JUAN CAPISTRANO | CA | 92675 |
| K983992 | NICHOLS INSTITUTE DIAGNOSTICS |
33051 CALLE AVIADOR | SAN JUAN CAPISTRANO | CA | 92675 |
| K151799 | PHADIA AB |
RAPSGATAN 7P | UPPSALA | SE 754 50 | |
| K981559 | PHARMACIA & UPJOHN CO. |
5094 ST. ANDREWS DR. | WESTERVILLLE | OH | 43082 |
| K981930 | PHARMACIA & UPJOHN CO. |
5094 ST. ANDREWS DR. | WESTERVILLLE | OH | 43082 |
| K003414 | PHARMACIA & UPJOHN CO. |
5094 ST. ANDREWS DR. | WESTERVILLLE | OH | 43082 |
| K993585 | PHARMACIA & UPJOHN CO. |
5094 ST. ANDREWS DR. | WESTERVILLLE | OH | 43082 |
| K023593 | QUEST INTL., INC. |
1938 N.E. 148TH TERR. | NORTH MIAMI | FL | 33181 |
| K222610 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K193313 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46256 |
| K020672 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K000155 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K080092 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. BX 50416 | INDIANAPOLIS | IN | 46250-0416 |
| K051890 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K053426 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K011082 | SCIMEDX CORP. |
400 FORD RD. | DENVILLE | NJ | 07834 |
| K152061 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10591 |
| K984165 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K984163 | THE BINDING SITE, LTD. |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K090760 | THERATEST LABORATORIES, INC. |
1111 N. MAIN ST. | LOMBARD | IL | 60148 |
| K981522 | TOSOH MEDICS, INC. |
373 VINTAGE PARK DR. | FOSTER CITY | CA | 94404 |
| K981521 | TOSOH MEDICS, INC. |
373 VINTAGE PARK DR. | FOSTER CITY | CA | 94404 |
| K000362 | ZEUS SCIENTIFIC, INC. |
P.O. BOX 38 | RARITAN | NJ | 08869 |
| K033977 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
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