Cleared Traditional

GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138

K905096 · Amresco, Inc. · Chemistry
Nov 1990
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K905096 is an FDA 510(k) clearance for the GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138, a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on November 28, 1990, 15 days after receiving the submission on November 13, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K905096 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1990
Decision Date November 28, 1990
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

Similar Devices — JQB Kinetic Method, Gamma-glutamyl Transpeptidase

All 51
Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30
K974000 · Diagnostic Chemicals , Ltd. · Nov 1997
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
K973157 · Pointe Scientific, Inc., · Oct 1997
SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)
K971466 · Carolina Liquid Chemistries Corp. · May 1997
ROCHE COBAS IBTEGRA REAGENT CASSETTES
K964457 · Roche Diagnostic Systems, Inc. · Jan 1997
GAMMA-GLUTAMYL TRANSPEPTIDASE
K964916 · Derma Media Lab., Inc. · Jan 1997
GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM
K955770 · Abaxis, Inc. · Sep 1996