Cleared Traditional

GLUCOSE-SL-C ASSAY, MODEL 257-30

K023739 · Diagnostic Chemicals , Ltd. · Chemistry
Jan 2003
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K023739 is an FDA 510(k) clearance for the GLUCOSE-SL-C ASSAY, MODEL 257-30, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on January 17, 2003, 71 days after receiving the submission on November 7, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K023739 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2002
Decision Date January 17, 2003
Days to Decision 71 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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