Cleared Traditional

GAMMA-GLUTAMYL TRANSFERASE

K881626 · Tech-Co, Inc. · Chemistry
May 1988
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K881626 is an FDA 510(k) clearance for the GAMMA-GLUTAMYL TRANSFERASE, a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on May 27, 1988, 45 days after receiving the submission on April 12, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K881626 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1988
Decision Date May 27, 1988
Days to Decision 45 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