510(k) K002457 ยท KHE Reagent, Occult Blood
!NSURE FECAL OCCULT BLOOD TEST
| Applicant | Enterix, Inc., Falmouth, ME, US |
| Decision | Substantially Equivalent, Jan 12, 2001 |
| Received | Aug 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002457
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.