ENZYMATIC CHOLESTEROL REAGENT SET— 510(k) K871676

Name: FDA 510(k) clearance K871676
Creator: U.S. Food and Drug Administration
Published: 1987-05-18

Substantially Equivalent

Michclone Associates, Inc.

FDA 510(k) clearance K871676 for ENZYMATIC CHOLESTEROL REAGENT SET, Substantially Equivalent on 1987-05-18. Applicant: Michclone Associates, Inc.. Device class: 1.

Clearance details

Applicant: Michclone Associates, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1987-04-28
Decision date: 1987-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

Download summary PDF View on FDA.gov ↗

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