510(k) K113438 ยท JMO Ferrozine (Colorimetric) Iron Binding Capacity
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Jun 1, 2012 |
| Received | Nov 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113438
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.