510(k) K131975 ยท CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Oct 2, 2013 |
| Received | Jun 28, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131975
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.