510(k) K993590 ยท LCP Assay, Glycosylated Hemoglobin
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Dec 21, 1999 |
| Received | Oct 22, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993590
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.