Cleared Traditional

GLUCOSE REAGENT

K970664 · Derma Media Lab., Inc. · Chemistry
Aug 1997
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K970664 is an FDA 510(k) clearance for the GLUCOSE REAGENT, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on August 1, 1997, 161 days after receiving the submission on February 21, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K970664 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1997
Decision Date August 01, 1997
Days to Decision 161 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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