FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Procainamide
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K955444 | ABBOTT LABORATORIES |
DEPT: 09V8 BLDG: AP5-2 | ABBOTT PARK | IL | 60064-3500 |
| K971716 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K963306 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524-4117 |
| K962099 | BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. | CONCORD | CA | 94524-4117 |
| K032573 | DADE BEHRING, INC. |
GLASGOW BUSINESS COMMUNITY; | P.O. BOX 6101, NEWARK | DE | 19714-6101 |
| K962463 | DIAGNOSTIC REAGENTS, INC. |
601 CALIFORNIA AVE. | SUNNYVALE | CA | 94086 |
| K060773 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K010812 | SYVA CO., DADE BEHRING, INC. |
P.O. BOX 49013 | SAN JOSE | CA | 95135 |
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