510(k) K053411 ยท LCP Assay, Glycosylated Hemoglobin
DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
| Applicant | Microgenics Corp., Fremont Blvd. CA, US |
| Decision | Substantially Equivalent, Feb 3, 2006 |
| Received | Dec 7, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053411
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.