K113438

Substantially Equivalent

ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT

Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
Product code: JMO
Advisory panel: Clinical Chemistry
Date received: 2011-11-21
Decision date: 2012-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

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