Cleared Traditional

SIGMA GLUCOSE REAGENT

K933694 · Sigma Chemical Co. · Chemistry
Nov 1994
Decision
463d
Days
Class 2
Risk

About This 510(k) Submission

K933694 is an FDA 510(k) clearance for the SIGMA GLUCOSE REAGENT, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on November 4, 1994, 463 days after receiving the submission on July 29, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K933694 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1993
Decision Date November 04, 1994
Days to Decision 463 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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