Cleared Traditional

GLUCOSE (GOD) REAGENT

K890336 · Alpkem Corp. · Chemistry
Feb 1989
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K890336 is an FDA 510(k) clearance for the GLUCOSE (GOD) REAGENT, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on February 27, 1989, 35 days after receiving the submission on January 23, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K890336 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 1989
Decision Date February 27, 1989
Days to Decision 35 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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