Cleared Traditional

GLUCOSE-SUPER FAST 4983050 AND 4983500

K882262 · American Research Products Co. · Chemistry
Feb 1989
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K882262 is an FDA 510(k) clearance for the GLUCOSE-SUPER FAST 4983050 AND 4983500, 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 February 2, 1989, 247 days after receiving the submission on May 31, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K882262 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1988
Decision Date February 02, 1989
Days to Decision 247 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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