Cleared Traditional

POLY-CHEM GLUCOSE

K020852 · Polymedco, Inc. · Chemistry
Jul 2002
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K020852 is an FDA 510(k) clearance for the POLY-CHEM GLUCOSE, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on July 3, 2002, 110 days after receiving the submission on March 15, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K020852 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2002
Decision Date July 03, 2002
Days to Decision 110 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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