510(k) K091711 ยท LCP Assay, Glycosylated Hemoglobin
S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Dec 11, 2009 |
| Received | Jun 10, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091711
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.