510(k) K023654 ยท LCP Assay, Glycosylated Hemoglobin
GLYCA-DIRECT FRUCTOSAMINE
| Applicant | Polymedco, Inc., Cortlandt Manor NY, US |
| Decision | Substantially Equivalent, May 2, 2003 |
| Received | Oct 30, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023654
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.