Cleared Traditional

GLUCOSE LIQUID AMRESCO #4628300 & 4628001L

K884909 · American Research Products Co. · Chemistry
Jan 1989
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K884909 is an FDA 510(k) clearance for the GLUCOSE LIQUID AMRESCO #4628300 & 4628001L, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on January 3, 1989, 41 days after receiving the submission on November 23, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K884909 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 1988
Decision Date January 03, 1989
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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