510(k) K962231 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
COBAS CORE IMMUNOCHEMISTRY SYSTEM
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Aug 30, 1996 |
| Received | Jun 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962231
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.