510(k) K920402 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
ROCHE COBAS MIRA PLUS
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Apr 29, 1992 |
| Received | Jan 31, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920402
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.