Cleared Traditional

ENZYMATIC CHOLESTEROL REAGENT SET

K871676 · Michclone Associates, Inc. · Chemistry

May 1987

Decision

20d

Days

Class 1

Risk

About This 510(k) Submission

K871676 is an FDA 510(k) clearance for the ENZYMATIC CHOLESTEROL REAGENT SET, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Michclone Associates, Inc. (Detroit, US). The FDA issued a Cleared decision on May 18, 1987, 20 days after receiving the submission on April 28, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number	K871676 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 1987
Decision Date	May 18, 1987
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—