510(k) K894081 ยท CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes
ROCHO ISOMUNE - LD
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Aug 31, 1989 |
| Received | Jun 8, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894081
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.