510(k) K123018— ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE

Substantially Equivalent

Alfa Wassermann Diagnostic Technologies, Inc.

Clearance details

Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
Product code: Code CFR
Advisory panel: Clinical Chemistry
Date received: 2012-09-28
Decision date: 2013-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

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