510(k) K080073 ยท JFY Enzymatic Method, Creatinine
S-TEST CREATININE (CRE)
| Applicant | Alfa Wassermann, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Jun 30, 2008 |
| Received | Jan 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080073
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.