510(k) K970477 ยท CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT
| Applicant | Sebia, Chelsea MI, US |
| Decision | Substantially Equivalent, Mar 10, 1997 |
| Received | Feb 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970477
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.