Cleared Traditional

GLUCOKEY

K831194 · Ulster Scientific, Inc. · Hematology
Oct 1983
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K831194 is an FDA 510(k) clearance for the GLUCOKEY, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Ulster Scientific, Inc. (Walker, US). The FDA issued a Cleared decision on October 31, 1983, 202 days after receiving the submission on April 12, 1983. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K831194 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1983
Decision Date October 31, 1983
Days to Decision 202 days
Submission Type Traditional
Review Panel Hematology (HE)
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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