510(k) K122757 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Oct 5, 2012 |
| Received | Sep 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122757
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.