510(k) K122101 ยท LCP Assay, Glycosylated Hemoglobin
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
| Applicant | Sebia, Norcross GA, US |
| Decision | Substantially Equivalent, Dec 6, 2012 |
| Received | Jul 16, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122101
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.