510(k) K113437 ยท LCP Assay, Glycosylated Hemoglobin
ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Aug 6, 2012 |
| Received | Nov 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113437
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.