510(k) K812428 ยท KHE Reagent, Occult Blood
HELENA COLOSCREEN METHOD
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 23, 1981 |
| Received | Aug 25, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812428
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.