510(k) K840527 ยท KHE Reagent, Occult Blood
COLOTRAK OCCULT BLOOD TEST
| Applicant | Breit Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 5, 1984 |
| Received | Feb 7, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840527
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.