Cleared Traditional

ROCHE COBAS READY GGT REAGENT

K903304 · Roche Diagnostic Systems, Inc. · Chemistry
Oct 1990
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K903304 is an FDA 510(k) clearance for the ROCHE COBAS READY GGT REAGENT, a Colorimetric Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JPZ), submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on October 12, 1990, 80 days after receiving the submission on July 24, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K903304 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1990
Decision Date October 12, 1990
Days to Decision 80 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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