510(k) K051806 ยท KHE Reagent, Occult Blood
CARE FECAL OCCULT BLOOD TEST, MODEL KT313
| Applicant | Epitope Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 3, 2005 |
| Received | Jul 5, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051806
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.