Cleared Traditional

ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA

K830239 · Emd Chemicals, Inc. · Chemistry
Apr 1983
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K830239 is an FDA 510(k) clearance for the ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1983, 70 days after receiving the submission on January 25, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K830239 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1983
Decision Date April 05, 1983
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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