Kinetic Method, Gamma-Glutamyl Transpeptidase

FDA product code JQB · 52 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.1360
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-12-02 – 1997-11-04

JQB 1997-11-04

Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30

Applicant Diagnostic Chemicals , Ltd.

K number K974000

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JQB 1997-10-10

LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K973157

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JQB 1997-05-06

SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)

Applicant Carolina Liquid Chemistries Corp.

K number K971466

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JQB 1997-01-13

ROCHE COBAS IBTEGRA REAGENT CASSETTES

Applicant Roche Diagnostic Systems, Inc.

K number K964457

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JQB 1997-01-10

GAMMA-GLUTAMYL TRANSPEPTIDASE

Applicant Derma Media Lab., Inc.

K number K964916

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JQB 1996-09-09

GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM

Applicant Abaxis, Inc.

K number K955770

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JQB 1995-06-09

Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05

Applicant Diagnostic Chemicals , Ltd.

K number K945800

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JQB 1995-05-02

HICHEM Y-GT REAGENT KIT

Applicant Hichem Diagnostics

K number K946192

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JQB 1994-12-07

GGT QVET

Applicant Prisma Systems

K number K942962

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JQB 1994-07-20

GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419

Applicant Sigma Diagnostics, Inc.

K number K935984

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JQB 1994-07-14

STANBIO Y-GT (LIQUICOLOR) TEST SET

Applicant Stanbio Laboratory

K number K941315

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JQB 1993-12-16

GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST

Applicant Em Diagnostic Systems, Inc.

K number K935177

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JQB 1993-09-08

SYNERMED GGT REAGENT KIT

Applicant Synermed, Inc.

K number K931958

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JQB 1993-01-26

OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT

Applicant Olympus Corp.

K number K925337

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JQB 1992-11-18

ROCHE REAGENT FOR GGT

Applicant Roche Diagnostic Systems, Inc.

K number K924246

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JQB 1992-09-28

GAMMA GULTAMYL TRANSFERASE TEST

Applicant Em Diagnostic Systems, Inc.

K number K922947

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JQB 1992-06-25

OLYMPUS GGT REAGENT

Applicant Olympus Corp.

K number K922230

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JQB 1991-11-19

TRACE GAMMA GT-SS REAGENT

Applicant Trace Scientific , Ltd.

K number K914731

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JQB 1991-07-26

ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST

Applicant Em Diagnostic Systems, Inc.

K number K913024

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JQB 1991-01-30

GAMMA-GLUTAMYL TRANSFERASE DETERMINATION

Applicant Biochemical Trade, Inc.

K number K905649

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JQB 1991-01-04

SYSTEMATE GGT (EPOS APPLICATION) #65414

Applicant Em Diagnostic Systems, Inc.

K number K905662

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JQB 1990-12-20

RAICHEM GGT REAGENT

Applicant Reagents Applications, Inc.

K number K905085

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JQB 1990-11-28

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

Applicant Amresco, Inc.

K number K905096

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JQB 1990-04-16

COULTER GAMMA-GT (GGT) REAGENT

Applicant Coulter Corp.

K number K901264

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JQB 1989-07-20

GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1

Applicant Em Diagnostic Systems, Inc.

K number K893765

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JQB 1989-03-24

GAMMA-GLUTAMYLTRANSFERASE

Applicant American Monitor Corp.

K number K890312

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JQB 1989-01-13

GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664

Applicant Em Diagnostic Systems, Inc.

K number K884988

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JQB 1988-05-27

GAMMA-GLUTAMYL TRANSFERASE

Applicant Tech-Co, Inc.

K number K881626

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JQB 1988-04-28

BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST

Applicant Biotrol, USA, Inc.

K number K881311

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JQB 1987-09-08

GAMMA GLUTAMYLTRANSFERASE

Applicant Catachem, Inc.

K number K873378

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JQB 1987-09-04

UNIFAST GAMMA-GT

Applicant Sclavo, Inc.

K number K873135

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JQB 1987-07-27

EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95

Applicant Em Diagnostic Systems, Inc.

K number K872322

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JQB 1987-07-27

EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616

Applicant Em Diagnostic Systems, Inc.

K number K872320

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JQB 1986-04-09

EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93

Applicant Em Diagnostic Systems, Inc.

K number K860640

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JQB 1985-06-10

G-GT REAGENT

Applicant Alpkem Corp.

K number K851999

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JQB 1985-02-12

Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT

Applicant Sigma Diagnostics, Inc.

K number K850319

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JQB 1984-12-12

GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED

Applicant Data Medical Associates, Inc.

K number K844720

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JQB 1984-09-13

SYSTEMATE 2GT - 67207

Applicant Em Diagnostic Systems, Inc.

K number K843268

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JQB 1984-02-04

DART GAMMA-GT REAGENT SYSTEM

Applicant Coulter Electronics, Inc.

K number K834054

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JQB 1983-12-29

FLOW-PAC GGT REAGENT SET

Applicant American Research Products Co.

K number K833029

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JQB 1983-10-14

PARAMAX & GLUTAMYTRANSFERASE REAGENT

Applicant American Dade

K number K833001

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JQB 1983-02-28

ULTRA ZYME PLUS GAMMA GT #65055 & 56

Applicant Emd Chemicals, Inc.

K number K830308

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JQB 1983-02-18

CAST SHOE, CAST BOOT

Applicant Warm & Form, Orthopedic Materials

K number K830246

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JQB 1983-02-18

ULTRAZYME PLUS GAMMA GT-MCA #65055-65056

Applicant Emd Chemicals, Inc.

K number K830240

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JQB 1983-01-28

ULTRAZYME PLUS GAMMA-GT, #64959/65032

Applicant Emd Chemicals, Inc.

K number K823883

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JQB 1982-02-12

ULTRAZYME PLUS GAMMA GT(65055-65056)

Applicant Harleco

K number K820233

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JQB 1981-11-10

ULTRAZYME-GT, ITEM #64959 & 65032

Applicant Harleco

K number K813041

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JQB 1981-08-31

GAMMA GLUTAMY TRANSPEPTIDASE

Applicant Pointe Scientific, Inc.,

K number K812296

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JQB 1981-02-26

GAMMA-GT REAGENT SYSTEM

Applicant American Monitor Corp.

K number K810434

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JQB 1980-04-24

Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST

Applicant Sclavo, Inc.

K number K800769

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JQB 1978-02-14

GAMA-GPT REAGENT SET

Applicant Medical Analysis Systems, Inc.

K number K780071

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JQB 1976-12-02

DIAGNOSTIC METHOD-8-GLUTAMYLTRANSFERASE

Applicant Technicon Instruments Corp.

K number K761090

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