510(k) K151809 ยท LCP Assay, Glycosylated Hemoglobin
Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
| Applicant | Alere Technologies AS, Oslo, NO |
| Decision | Substantially Equivalent, Sep 25, 2015 |
| Received | Jul 2, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151809
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.