510(k) K110056 ยท LCP Assay, Glycosylated Hemoglobin
AFINION ANALYZER
| Applicant | Axis-Shield Poc AS, Oslo, NO |
| Decision | Substantially Equivalent, Feb 15, 2011 |
| Received | Jan 10, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110056
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.