510(k) K843352 ยท KHE Reagent, Occult Blood
COLOSCREEN SELF-TEST
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Dec 5, 1984 |
| Received | Aug 27, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843352
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.