Enzymatic Cholesterol Reagent Set

FDA 510(k) K871676 · Michclone Associates, Inc.

Substantially Equivalent

510(k) numberK871676

Submission

Device name
Enzymatic Cholesterol Reagent Set
Applicant
Michclone Associates, Inc.
Detroit, MI, US
Received
April 28, 1987
Decision date
May 18, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CHH – Enzymatic Esterase--Oxidase, Cholesterol
Device class
Class I (low risk)
Regulation
21 CFR 862.1175
Specialty
Clinical Chemistry

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Questions and answers

When was Enzymatic Cholesterol Reagent Set cleared by the FDA?

Enzymatic Cholesterol Reagent Set (K871676) received a 510(k) decision of Substantially Equivalent on May 18, 1987, 20 days after the submission was received.

What is the product code of K871676?

The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.