Cleared Traditional

CENTRIFICHEM CHOLESTEROL

K800765 · Union Carbide Corp. · Chemistry
Apr 1980
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K800765 is an FDA 510(k) clearance for the CENTRIFICHEM CHOLESTEROL, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1980, 17 days after receiving the submission on April 7, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K800765 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1980
Decision Date April 24, 1980
Days to Decision 17 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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