510(k) K112538— ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT

Substantially Equivalent

Alfa Wassermann Diagnostic Technologies, Inc.

Clearance details

Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
Product code: Code CHH
Advisory panel: Clinical Chemistry
Date received: 2011-09-01
Decision date: 2012-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

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