FDA 510(k) Applications for Medical Device:
Enzyme Immunoassay, Quinidine
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K964116 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K964212 | DIAGNOSTIC REAGENTS, INC. |
601 CALIFORNIA AVE. | SUNNYVALE | CA | 94086 |
| K955568 | OXIS INTL., INC. |
6040 NORTH CUTTER CIR., #317 | PORTLAND | OR | 97217-3935 |
| K032332 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K052826 | SERADYN INC. |
7998 GEORGETOWN RD. | INDIANAPOLIS | IN | 46268-5260 |
| K011605 | SYVA CO., DADE BEHRING, INC. |
3404 YERBA BUENA RD. | SAN JOSE | CA | 95135 |
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