Cleared Traditional

K040971 - GENCHEM ISE ELECTROLYTE REFERENCE
(FDA 510(k) Clearance)

K040971 · Genchem, Inc. · Chemistry

Dec 2004

Decision

252d

Days

Class 2

Risk

K040971 is an FDA 510(k) clearance for the GENCHEM ISE ELECTROLYTE REFERENCE, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Genchem, Inc. (Brea, US). The FDA issued a Cleared decision on December 22, 2004, 252 days after receiving the submission on April 14, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number	K040971 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2004
Decision Date	December 22, 2004
Days to Decision	252 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF