Cleared Traditional

CARESIDE GGT

K020486 · Careside, Inc. · Chemistry
Jul 2002
Decision
138d
Days
Class 1
Risk

About This 510(k) Submission

K020486 is an FDA 510(k) clearance for the CARESIDE GGT, a Colorimetric Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JPZ), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on July 1, 2002, 138 days after receiving the submission on February 13, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K020486 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2002
Decision Date July 01, 2002
Days to Decision 138 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JPZ — Colorimetric Method, Gamma-glutamyl Transpeptidase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1360

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