510(k) K003359 ยท KHE Reagent, Occult Blood
COLOSCREEN-ES
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Nov 27, 2000 |
| Received | Oct 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003359
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.