Cleared Traditional

COULTER CHOLESTEROL REAGENT

K897162 · Coulter Electronics, Inc. · Chemistry
Mar 1990
Decision
91d
Days
Class 1
Risk

About This 510(k) Submission

K897162 is an FDA 510(k) clearance for the COULTER CHOLESTEROL REAGENT, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on March 29, 1990, 91 days after receiving the submission on December 28, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K897162 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1989
Decision Date March 29, 1990
Days to Decision 91 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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