ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT— 510(k) K113436

Name: FDA 510(k) clearance K113436
Creator: U.S. Food and Drug Administration
Published: 2012-07-12

Substantially Equivalent

Alfa Wassermann

FDA 510(k) clearance K113436 for ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT, Substantially Equivalent on 2012-07-12. Applicant: Alfa Wassermann. Device class: 2.

Clearance details

Applicant: Alfa Wassermann
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2011-11-21
Decision date: 2012-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

Download summary PDF View on FDA.gov ↗

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