K113262

Substantially Equivalent

ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT

Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
Product code: CHH
Advisory panel: Clinical Chemistry
Date received: 2011-11-04
Decision date: 2012-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

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