510(k) K082226 ยท JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
S40 CREATINE KINASE (CK)
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Sep 18, 2008 |
| Received | Aug 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082226
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.