K131351

Substantially Equivalent

ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT

Applicant: Alfa Wassermann Diagnostic Technologies, LLC
Product code: CJE
Advisory panel: Clinical Chemistry
Date received: 2013-05-10
Decision date: 2013-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

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