510(k) K162281 ยท LCP Assay, Glycosylated Hemoglobin
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
| Applicant | Sebia, Norcross GA, US |
| Decision | Substantially Equivalent, Feb 17, 2017 |
| Received | Aug 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162281
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.