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JPZ — Colorimetric Method, Gamma-Glutamyl Transpeptidase Class I

FDA Device Classification

Classification Details

Product Code
JPZ
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
K020486caresideCARESIDE GGTJuly 1, 2002
K961919data medical associatesDMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREJuly 1, 1996
K923509randox laboratoriesGAMMA-GTDecember 3, 1992
K923091king diagnosticsKING DIAGNOSTICS GAMMA GT REAGENTSeptember 9, 1992
K905618amrescoGGT REAGENTFebruary 26, 1991
K903304roche diagnostic systemsROCHE COBAS READY GGT REAGENTOctober 12, 1990
K901090elite technologyELITECH GAMMA GT TEST KITMarch 29, 1990
K895984wako chemicals usaWAKO(TM) AUTOKIT GAMMA-GTNovember 8, 1989
K881239tech-neal scientificGAMMA GLUTAMYL TRANSFERASE REAGENT SETMay 31, 1988
K874903simmlerMULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)February 11, 1988
K871979intersect systemsGAMMA GLUTAMYLTRANSFERASE REAGENTJune 11, 1987
K864208abbott laboratoriesVISION (TM) GGTPNovember 24, 1986
K863586data medical associatesGAMMA GLUTAMYL TRANSFERASE PROCEDUREOctober 3, 1986
K861672data medical associatesGAMMA GLUTAMYL TRANSFERASE PROCEDUREMay 29, 1986
K860723trace scientificG.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENTApril 7, 1986
K860348sterling diagnosticsGAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SETMarch 17, 1986
K855186technostics intlGAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSETJanuary 14, 1986
K855156technostics intlGAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SETJanuary 14, 1986
K850788diagnostic chemicals, ltd. (usa)GLUTAMYLTRANSFERASE ASSAY KITMarch 19, 1985
K842104advocacy internationalTOYO JOZO G-GTP TESTAugust 10, 1984