510(k) K232027 ยท GKA Abnormal Hemoglobin Quantitation
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
| Applicant | Sebia, Norcross GA, US |
| Decision | Substantially Equivalent, Apr 4, 2024 |
| Received | Jul 7, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232027
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.