Cleared Traditional

GLUCOSE REAGENT B6360-11

K831634 · American Scientific Products · Chemistry
Jul 1983
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K831634 is an FDA 510(k) clearance for the GLUCOSE REAGENT B6360-11, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983, 60 days after receiving the submission on May 20, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K831634 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1983
Decision Date July 19, 1983
Days to Decision 60 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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