K123322

Substantially Equivalent

ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT

Applicant: Alfa Wassermann Diagnostics Technologies, LLC
Product code: CDN
Advisory panel: Clinical Chemistry
Date received: 2012-10-26
Decision date: 2013-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

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