510(k) K050574 ยท LCP Assay, Glycosylated Hemoglobin
AFINION HBALC
| Applicant | Axis-Shield Poc AS, San Diego CA, US |
| Decision | Substantially Equivalent, Jul 22, 2005 |
| Received | Mar 7, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050574
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.