Cleared Traditional

ULTRA-VIOLET GLUCOSE REAGENT KIT

K871456 · Biochemical Trade, Inc. · Chemistry
Apr 1987
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K871456 is an FDA 510(k) clearance for the ULTRA-VIOLET GLUCOSE REAGENT KIT, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on April 29, 1987, 16 days after receiving the submission on April 13, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K871456 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1987
Decision Date April 29, 1987
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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