510(k) K031296 ยท LCP Assay, Glycosylated Hemoglobin
LIQUI-HEME GLYCO A1C ASSAY
| Applicant | Biodiagnostic Intl, Brea CA, US |
| Decision | Substantially Equivalent, Oct 15, 2004 |
| Received | Apr 23, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031296
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.