510(k) K163554 ยท KHE Reagent, Occult Blood
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
| Applicant | Immunostics Inc.,, Ocean NJ, US |
| Decision | Substantially Equivalent, Jan 17, 2017 |
| Received | Dec 19, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163554
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.