510(k) K100817 ยท KHE Reagent, Occult Blood
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, Jul 1, 2010 |
| Received | Mar 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100817
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.