Cleared Traditional

KING DIAGNOSTICS GAMMA GT REAGENT

K923091 · King Diagnostics, Inc. · Chemistry
Sep 1992
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K923091 is an FDA 510(k) clearance for the KING DIAGNOSTICS GAMMA GT REAGENT, a Colorimetric Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JPZ), submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 9, 1992, 76 days after receiving the submission on June 25, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K923091 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 1992
Decision Date September 09, 1992
Days to Decision 76 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