510(k) K031356 ยท KHE Reagent, Occult Blood
HEMAPROMPT GASTRIC
| Applicant | Aerscher Diagnostics, Chestertown MD, US |
| Decision | Substantially Equivalent, Sep 24, 2003 |
| Received | Apr 11, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031356
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.