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JQB — Kinetic Method, Gamma-Glutamyl Transpeptidase Class I

FDA Device Classification

Classification Details

Product Code
JQB
Device Class
Class I
Regulation Number
862.1360
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K974000diagnostic chemicalsY-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30November 4, 1997
K973157pointe scientific, incLIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SETOctober 10, 1997
K971466carolina liquid chemistriesSYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)May 6, 1997
K964457roche diagnostic systemsROCHE COBAS IBTEGRA REAGENT CASSETTESJanuary 13, 1997
K964916derma media labGAMMA-GLUTAMYL TRANSPEPTIDASEJanuary 10, 1997
K955770abaxisGAMMA GLUTAMYL TRANSFERASE TEST SYSTEMSeptember 9, 1996
K945800diagnostic chemicalsY-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05June 9, 1995
K946192hichem diagnosticsHICHEM Y-GT REAGENT KITMay 2, 1995
K942962prisma systemsGGT QVETDecember 7, 1994
K935984sigma diagnosticsGLUTAMYL-TRANSFERASE, PROCEDURE NO. 419July 20, 1994
K941315stanbio laboratorySTANBIO Y-GT (LIQUICOLOR) TEST SETJuly 14, 1994
K935177em diagnostic systemsGAMMA-GLUTAMYL TRANSFERASE (GGT) TESTDecember 16, 1993
K931958synermedSYNERMED GGT REAGENT KITSeptember 8, 1993
K925337olympusOLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENTJanuary 26, 1993
K924246roche diagnostic systemsROCHE REAGENT FOR GGTNovember 18, 1992
K922947em diagnostic systemsGAMMA GULTAMYL TRANSFERASE TESTSeptember 28, 1992
K922230olympusOLYMPUS GGT REAGENTJune 25, 1992
K914731trace scientificTRACE GAMMA GT-SS REAGENTNovember 19, 1991
K913024em diagnostic systemsABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TESTJuly 26, 1991
K905649biochemical tradeGAMMA-GLUTAMYL TRANSFERASE DETERMINATIONJanuary 30, 1991