510(k) K163225 ยท OOX Automated Occult Blood Analyzer
AFIAS iFOB with AFIAS-50
| Applicant | Immunostics Inc.,, Ocean NJ, US |
| Decision | Substantially Equivalent, Aug 8, 2017 |
| Received | Nov 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163225
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.