Cleared Traditional

TOTAL CHOLESTEROL REAGENT

K890334 · Alpkem Corp. · Chemistry
May 1989
Decision
100d
Days
Class 1
Risk

About This 510(k) Submission

K890334 is an FDA 510(k) clearance for the TOTAL CHOLESTEROL REAGENT, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on May 3, 1989, 100 days after receiving the submission on January 23, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K890334 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 1989
Decision Date May 03, 1989
Days to Decision 100 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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