510(k) K901064 ยท KHE Reagent, Occult Blood
MONOHAEM (FECAL OCCULT BLOOD TEST)
| Applicant | Silenus Laboratories Proprietary , Ltd., Wilmington DE, US |
| Decision | Substantially Equivalent, Nov 5, 1990 |
| Received | Mar 7, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901064
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.