510(k) K173212 ยท KHE Reagent, Occult Blood
Instant-view-PLUS immunochemical Fecal Occult Blood Test
| Applicant | Alfa Scientific Designs, Inc., Powat CA, US |
| Decision | Substantially Equivalent, Feb 15, 2018 |
| Received | Oct 2, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173212
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.