ACE MAGNESIUM REGENT— 510(k) K122302

Substantially Equivalent

Alfa Wassermann Diagnostics Technologies, LLC

FDA 510(k) clearance K122302 for ACE MAGNESIUM REGENT, Substantially Equivalent on 2012-08-27. Applicant: Alfa Wassermann Diagnostics Technologies, LLC.

Clearance details

Applicant: Alfa Wassermann Diagnostics Technologies, LLC
Product code: Code JGJ
Advisory panel: Clinical Chemistry
Date received: 2012-08-01
Decision date: 2012-08-27
Decision: Substantially Equivalent
Clearance type: Special
Location: West Caldwell, NJ, US

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