CHOLESTRAK HDL CHOLESTEROL HOME TEST— 510(k) K072836

Substantially Equivalent

Accutech, LLC

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

Clearance details

Applicant: Accutech, LLC
Product code: Code LBS
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 ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.