510(k) K113389 ยท CDN Urease, Photometric, Urea Nitrogen
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Aug 10, 2012 |
| Received | Nov 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113389
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.