510(k) K171537 ยท PDJ Hemoglobin A1c Test System
CAPI 3 Hb A1c
| Applicant | Sebia, Norcross GA, US |
| Decision | Substantially Equivalent, Sep 12, 2017 |
| Received | May 25, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171537
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.