Cleared Traditional

CHOLESTEROL (RATE) REAGENT

K902098 · Sigma Chemical Co. · Chemistry
Aug 1990
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K902098 is an FDA 510(k) clearance for the CHOLESTEROL (RATE) REAGENT, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on August 9, 1990, 93 days after receiving the submission on May 8, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K902098 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1990
Decision Date August 09, 1990
Days to Decision 93 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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