Cleared Special

GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150

K000102 · Teco Diagnostics · Chemistry
Feb 2000
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K000102 is an FDA 510(k) clearance for the GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on February 8, 2000, 26 days after receiving the submission on January 13, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K000102 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2000
Decision Date February 08, 2000
Days to Decision 26 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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