HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY— 510(k) K040293

Name: FDA 510(k) clearance K040293
Creator: U.S. Food and Drug Administration
Published: 2004-05-28

Substantially Equivalent

Akers Laboratories, Inc.

FDA 510(k) clearance K040293 for HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY, Substantially Equivalent on 2004-05-28. Applicant: Akers Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Akers Laboratories, Inc.
Product code: Code LCO
Device class: Class 2
Regulation: 21 CFR 864.7695
Advisory panel: Hematology
Date received: 2004-02-06
Decision date: 2004-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thorofare, NJ, US

Download summary PDF View on FDA.gov ↗

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