COBAS BACT
FDA premarket approval P840065 · decided 1986-05-30
Approval details
- PMA number
- P840065
- Trade name
- COBAS BACT
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Applicant
- Roche Diagnostics GmbH
- Date received
- 1984-11-30
- Decision date
- 1986-05-30
- Days to decision
- 546 days
- Decision code
- APRL
- Product code
- LON
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Montclair, NJ
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Calcitonin (K252431) | Roche Diagnostics GmbH | 2026-04-24 |
| Accu-Chek FlexLink Plus infusion set (K143446) | Roche Diagnostics GmbH | 2015-08-13 |
| ELECSYS AFP (K981282) | Roche Diagnostics GmbH | 1998-05-01 |
| ELECSYS CALCHECK FERRITIN (K981281) | Roche Diagnostics GmbH | 1998-04-24 |
| ELECSYS CALCHECK CA 125II (K981278) | Roche Diagnostics GmbH | 1998-04-23 |