510(k) K892818 ยท CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes
REP(TM) LD-2 STAT KIT, CAT. NO. 3078
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jun 20, 1989 |
| Received | Apr 17, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892818
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.