510(k) K072686 ยท LCP Assay, Glycosylated Hemoglobin
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Mar 17, 2008 |
| Received | Sep 24, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072686
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.