Cleared Traditional

CHOL OR CHOLESTEROL

K971345 · Carolina Liquid Chemistries Corp. · Chemistry
May 1997
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K971345 is an FDA 510(k) clearance for the CHOL OR CHOLESTEROL, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on May 29, 1997, 49 days after receiving the submission on April 10, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K971345 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 1997
Decision Date May 29, 1997
Days to Decision 49 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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