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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 |
|---|---|---|---|---|---|
| K990978 | A.P. TOTAL CARE, INC. |
70 HAWLEY AVE, | BRIDGEPORT | CT | |
| K203530 | Abbott Ireland Diagnostics Division |
Lisnamuck | Longford | ||
| K981814 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K981457 | ABBOTT MFG., INC. |
1920 HURD DR. | IRVING | TX | 75038 |
| K021636 | INTERSECT SYSTEMS, INC. |
P.O. BOX 2219 | LONGVIEW | WA | 98632 |
| K000483 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, CO. ANTRIM | BT29 4QY | |
| K193001 | Sentinel CH. SpA |
Via Robert Koch, 2 | Milano | 20152 | |
| K132664 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVE | TARRYTOWN | NY | 10591 |