510(k) K855237 ยท KHE Reagent, Occult Blood
BIOTEL (TM)/ KIDNEY
| Applicant | American Diagnostic Corp., Wheaton IL, US |
| Decision | Substantially Equivalent, May 6, 1986 |
| Received | Dec 31, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K855237
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.