Cleared Traditional

K040974 - GLUCOSE OXIDASE, GLUCOSE
(FDA 510(k) Clearance)

K040974 · Genchem, Inc. · Chemistry

Dec 2004

Decision

257d

Days

Class 2

Risk

K040974 is an FDA 510(k) clearance for the GLUCOSE OXIDASE, GLUCOSE, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Genchem, Inc. (Brea, US). The FDA issued a Cleared decision on December 27, 2004, 257 days after receiving the submission on April 14, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K040974 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2004
Decision Date	December 27, 2004
Days to Decision	257 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF