ACE Hemoglobin A1c (HbA1c) Reagent— 510(k) K170623

Name: FDA 510(k) clearance K170623
Creator: U.S. Food and Drug Administration
Published: 2018-02-27

Substantially Equivalent

Alfa Wassermann Diagnostic Technologies, LLC

FDA 510(k) clearance K170623 for ACE Hemoglobin A1c (HbA1c) Reagent, Substantially Equivalent on 2018-02-27. Applicant: Alfa Wassermann Diagnostic Technologies, LLC. Device class: 2.

Clearance details

Applicant: Alfa Wassermann Diagnostic Technologies, LLC
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2017-03-01
Decision date: 2018-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

Download summary PDF View on FDA.gov ↗

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