FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Gentamicin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K102699 | ABBOTT LABORATORIES |
100 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064-6092 |
| K962519 | BEHRING DIAGNOSTICS, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K962819 | DADE INTL., INC. |
BUILDING 500, MAILBOX 514 | NEWARK | DE | 19714-6101 |
| K012311 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K042479 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K012978 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | CRUMLIN | BT29 4QY | |
| K020704 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K060709 | SERADYN INC. |
7998 GEORGETOWN RD. | INDIANAPOLIS | IN | 46268-5260 |
| K010984 | SYVA CO., DADE BEHRING, INC. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95135 |
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