FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Diphenylhydantoin
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K080696 | ABBOTT LABORATORIES |
100 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064 |
| K963840 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524 |
| K000006 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K011393 | RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. | CRUMLIN, CO. ANTRIM | BT29 4QY | |
| K030428 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K973414 | SCHIAPPARELLI BIOSYSTEMS, INC. |
368 PASSAIC AVE. | FAIRFIELD | NJ | 07004 |
| K993026 | SYVA CO. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95161-9013 |
| K011347 | SYVA CO. |
3403 YERBA BUENA RD. | SAN JOSE | CA | 95135-1500 |
| K063145 | THERMO ELECTRON OY |
RATASTIE 2 | VANTAA | FIN-01621 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
