510(k) K214117 · LCP Assay, Glycosylated Hemoglobin
Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer
| Applicant | Abbott Diagnostics Technologies AS, Oslo, NO |
| Decision | Substantially Equivalent, Sep 27, 2023 |
| Received | Dec 30, 2021 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K214117
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.