ACE MAGNESIUM REGENT— 510(k) K122302

Name: FDA 510(k) clearance K122302
Creator: U.S. Food and Drug Administration
Published: 2012-08-27

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. Device class: 1.

Clearance details

Applicant: Alfa Wassermann Diagnostics Technologies, LLC
Product code: Code JGJ
Device class: Class 1
Regulation: 21 CFR 862.1495
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

Download summary PDF View on FDA.gov ↗

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