FDA 510(k) Applications for Medical Device:
|
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 |