| Device | 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 |
| Notice Date | 1986-07-07 |
| PMA | P840065 |
| Supplement | S |
| Product Code | LON |
| Docket Number | 86M-0249 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS GMBH 1 Sunset Ave. montclair, NJ 07042-5199 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840065 | Original Filing |