510(k) K062658 ยท LCP Assay, Glycosylated Hemoglobin
PRIMUS A1CARE ASSAY
| Applicant | Primus Corp., Kansas City MO, US |
| Decision | Substantially Equivalent, Nov 26, 2007 |
| Received | Sep 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062658
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.