Cleared Traditional

CHOLESTEROL REAGENT

K971072 · Derma Media Lab., Inc. · Chemistry
Jun 1997
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K971072 is an FDA 510(k) clearance for the CHOLESTEROL REAGENT, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on June 20, 1997, 88 days after receiving the submission on March 24, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K971072 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1997
Decision Date June 20, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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