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FDA 510(k) Applications for Medical Device:
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| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K981189 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K981766 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K955752 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K033278 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, COUNTY ANTRIM | BT29 4QY | |
| K982251 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST.LOUIS | MO | 63103 |
| K992798 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K971485 | TRACE AMERICA, INC. |
7260 NORTH WEST 58TH ST. | MIAMI | FL | 33166 |