510(k) K133344 ยท LCP Assay, Glycosylated Hemoglobin
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS
| Applicant | Sebia, Norcross GA, US |
| Decision | Substantially Equivalent, Mar 28, 2014 |
| Received | Oct 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133344
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.