510(k) K905798 ยท KHE Reagent, Occult Blood
COLOCARE
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jul 3, 1991 |
| Received | Nov 19, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905798
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.