JQBClass I

Kinetic Method, Gamma-Glutamyl Transpeptidase

21 CFR 862.1360 / Clinical Chemistry

JQB is the FDA product code for Kinetic Method, Gamma-Glutamyl Transpeptidase, a class I device type, regulated under 21 CFR 862.1360. As of 2026-09-10, FDA records hold 52 510(k) clearances under this code, the most recent dated 1997-11-04, and no recalls.

Classification record

Product code: JQB
Device name: Kinetic Method, Gamma-Glutamyl Transpeptidase
Regulation: 21 CFR 862.1360
Device class: Class I
Review panel: Clinical Chemistry
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 52
Ingested recalls: 0

Clearances, product code JQB

By decision year

52 clearances under product code JQB with a decision year between 1976 and 1997, 1983 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code JQB by decision year
Year	Clearances
1976	1
1978	1
1980	1
1981	3
1982	1
1983	6
1984	3
1985	2
1986	1
1987	4
1988	2
1989	3
1990	3
1991	4
1992	3
1993	3
1994	3
1995	2
1996	1
1997	5

Applicants with the most clearances

Product code JQB

Applicants holding the most 510(k) clearances under product code JQB
Applicant	Clearances
Em Diagnostic Systems, Inc.	10
EMD Millipore Corporation	3
American Monitor Corp.	2
Sekisui Diagnostics P.E.I. Inc.	2
Harleco	2
Olympus Corp.	2
Horiba Instruments Incorporated	2
Roche Diagnostic Systems, Inc.	2
Sclavo, Inc.	2
Sigma Diagnostics, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order