510(k) K180762 ยท GKA Abnormal Hemoglobin Quantitation
CAPI 3 HEMOGLOBIN(E)
| Applicant | Sebia, Norcross GA, US |
| Decision | Substantially Equivalent, Dec 14, 2018 |
| Received | Mar 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180762
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.