510(k) K101831 ยท OSL Control, Fecal Occult Blood
ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
| Applicant | Bionostics, Inc., Devens MA, US |
| Decision | Substantially Equivalent, Oct 1, 2010 |
| Received | Jul 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101831
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.