510(k) K093548 ยท LCP Assay, Glycosylated Hemoglobin
AVIE A1C TEST SYSTEM
| Applicant | Mec Dynamics Corp, San Jose CA, US |
| Decision | Substantially Equivalent, Jul 20, 2011 |
| Received | Nov 17, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093548
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.