510(k) K123322 ยท CDN Urease, Photometric, Urea Nitrogen
ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
| Applicant | Alfa Wassermann Diagnostics Technologies, LLC, West Caldwell NJ, US |
| Decision | Substantially Equivalent, May 21, 2013 |
| Received | Oct 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123322
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.