510(k) K110309 ยท KHE Reagent, Occult Blood
FOB ONE STEP RAPID TEST
| Applicant | Orient Gene Biotech, East Stroudsburg PA, US |
| Decision | Substantially Equivalent, Sep 14, 2011 |
| Received | Feb 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110309
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.