Cleared Traditional

AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325

K891922 · American Research Products Co. · Chemistry
Jun 1989
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K891922 is an FDA 510(k) clearance for the AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on June 16, 1989, 81 days after receiving the submission on March 27, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K891922 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1989
Decision Date June 16, 1989
Days to Decision 81 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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