510(k) K020532 ยท LCP Assay, Glycosylated Hemoglobin
POLYMEDCO HBA1C TEST
| Applicant | Polymedco, Inc., Cortlandt Manor NY, US |
| Decision | Substantially Equivalent, Apr 24, 2002 |
| Received | Feb 19, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020532
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.