510(k) K061944 ยท JFY Enzymatic Method, Creatinine
POLY-CHEM CREATININE
| Applicant | Polymedco, Inc., Cortlandt Manor NY, US |
| Decision | Substantially Equivalent, Nov 3, 2006 |
| Received | Jul 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061944
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.