510(k) K222635 ยท GKA Abnormal Hemoglobin Quantitation
Premier Resolution System
| Applicant | Trinity Biotech (Primus Corporation, Dba Trinity Biotech), Kansas City MO, US |
| Decision | Substantially Equivalent, Aug 4, 2023 |
| Received | Aug 31, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222635
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.