ACE ALT REAGENT— 510(k) K113382

Substantially Equivalent

Alfa Wassermann

FDA 510(k) clearance K113382 for ACE ALT REAGENT, Substantially Equivalent on 2012-07-19. Applicant: Alfa Wassermann.

Clearance details

Applicant: Alfa Wassermann
Product code: Code CKA
Advisory panel: Clinical Chemistry
Date received: 2011-11-16
Decision date: 2012-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

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