510(k) K073309 ยท LCP Assay, Glycosylated Hemoglobin
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
| Applicant | Horiba Abx, Montpellier, FR |
| Decision | Substantially Equivalent, Oct 17, 2008 |
| Received | Nov 23, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073309
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.