ENZYMATIC CHOLESTEROL KIT— 510(k) K820951

Name: FDA 510(k) clearance K820951
Creator: U.S. Food and Drug Administration
Published: 1982-04-26

Substantially Equivalent

Anco Medical Reagents & Assoc.

FDA 510(k) clearance K820951 for ENZYMATIC CHOLESTEROL KIT, Substantially Equivalent on 1982-04-26. Applicant: Anco Medical Reagents & Assoc.. Device class: 1.

Clearance details

Applicant: Anco Medical Reagents & Assoc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1982-04-06
Decision date: 1982-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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