CHOLESTRAK HDL CHOLESTEROL HOME TEST— 510(k) K072836

Name: FDA 510(k) clearance K072836
Creator: U.S. Food and Drug Administration
Published: 2007-12-27

Substantially Equivalent

Accutech, LLC

FDA 510(k) clearance K072836 for CHOLESTRAK HDL CHOLESTEROL HOME TEST, Substantially Equivalent on 2007-12-27. Applicant: Accutech, LLC. Device class: 1.

Clearance details

Applicant: Accutech, LLC
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2007-10-03
Decision date: 2007-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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