510(k) K022455 ยท CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes
SPIFE LD-12 KIT, MODEL 3338
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Oct 1, 2002 |
| Received | Jul 26, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022455
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.