Cleared Traditional

K874846 - GLUCOSE (HEXOKINASE)
(FDA 510(k) Clearance)

K874846 · Tech-Co, Inc. · Chemistry
Mar 1988
Decision
100d
Days
Class 2
Risk

K874846 is an FDA 510(k) clearance for the GLUCOSE (HEXOKINASE), a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on March 3, 1988, 100 days after receiving the submission on November 24, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K874846 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1987
Decision Date March 03, 1988
Days to Decision 100 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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