510(k) K113253 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, May 17, 2012 |
| Received | Nov 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113253
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.