510(k) K770613 ยท CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
LDH ULTRAZYME PLUS
| Applicant | Harleco Diagnostics, Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 17, 1977 |
| Received | Mar 31, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K770613
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.