Cleared Traditional

CHEMA CHOL CHOLESTEROL SYSTEM

K904031 · Texas Intl. Laboratories, Inc. · Chemistry
Mar 1991
Decision
192d
Days
Class 1
Risk

About This 510(k) Submission

K904031 is an FDA 510(k) clearance for the CHEMA CHOL CHOLESTEROL SYSTEM, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Texas Intl. Laboratories, Inc. (Houston, US). The FDA issued a Cleared decision on March 11, 1991, 192 days after receiving the submission on August 31, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K904031 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1990
Decision Date March 11, 1991
Days to Decision 192 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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