510(k) K031539 ยท LCP Assay, Glycosylated Hemoglobin
HEMOGLOBIN A1C REAGENT SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Aug 6, 2003 |
| Received | May 16, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031539
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.