510(k) K113262 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Jul 3, 2012 |
| Received | Nov 4, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113262
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.