Cleared Traditional

MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET

K002199 · Pointe Scientific, Inc., · Chemistry
Nov 2000
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K002199 is an FDA 510(k) clearance for the MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on November 20, 2000, 123 days after receiving the submission on July 20, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K002199 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2000
Decision Date November 20, 2000
Days to Decision 123 days
Submission Type Traditional
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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