510(k) K063306 ยท LCP Assay, Glycosylated Hemoglobin
ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72
| Applicant | Alfa Wassermann, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Apr 17, 2007 |
| Received | Nov 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063306
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.