510(k) K854585 ยท CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
ULTRAZYME PLUS & SYSTEMATE LDH
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Dec 5, 1985 |
| Received | Nov 18, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854585
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.