510(k) K860572 ยท LCP Assay, Glycosylated Hemoglobin
GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
| Applicant | Pointe Scientific, Inc.,, Detroit MI, US |
| Decision | Substantially Equivalent, May 16, 1986 |
| Received | Feb 14, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860572
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.