510(k) K131488 ยท CIX Bromcresol Green Dye-Binding, Albumin
ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT
| Applicant | Alfa Wassermann Diagnostics Technologies, LLC, West Caldwell NJ, US |
| Decision | Substantially Equivalent, Aug 19, 2013 |
| Received | May 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131488
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.