Product code JPZ— Clinical Chemistry
GAMMA GLUTAMYL TRANSFERASE PROCEDURE
- Classification name
- Colorimetric Method, Gamma-Glutamyl Transpeptidase
- Device class
- Class 1
- Regulation
- 21 CFR 862.1360
- Advisory panel
- Clinical Chemistry
- Total cleared
- 33
- First cleared
- Most recent
Market context for product code JPZ
FDA has cleared devices under product code JPZ between 1976 and 2002, filed by 28 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2002
- 1996
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
- 1982
- 1981
- 1979
Top applicants under product code JPZ
Recent clearances under product code JPZ
- K020486 — CARESIDE GGT
- K961919 — DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
- K923509 — GAMMA-GT
- K923091 — KING DIAGNOSTICS GAMMA GT REAGENT
- K905618 — GGT REAGENT
- K903304 — ROCHE COBAS READY GGT REAGENT
- K901090 — ELITECH GAMMA GT TEST KIT
- K895984 — WAKO(TM) AUTOKIT GAMMA-GT
- K881239 — GAMMA GLUTAMYL TRANSFERASE REAGENT SET
- K874903 — MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)
- K871979 — GAMMA GLUTAMYLTRANSFERASE REAGENT
- K864208 — VISION (TM) GGTP
- K863586 — GAMMA GLUTAMYL TRANSFERASE PROCEDURE
- K861672 — GAMMA GLUTAMYL TRANSFERASE PROCEDURE
- K860723 — G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT
- K860348 — GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET
- K855156 — GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET
- K855186 — GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET
- K850788 — GLUTAMYLTRANSFERASE ASSAY KIT
- K842104 — TOYO JOZO G-GTP TEST
- K831639 — WAKO R-GTP C-TEST
- K823090 — RAICHEM & GT REAGENT
- K822149 — GILCHEM Y-GT REAGENT
- K821871 — ULTRAZYME PLUS 2GT
- K821468 — ULTRAZYME PLUS-GT, #64959 & 65032
- K803089 — GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT)
- K790812 — COULTER ACCU-ZYME IIY-GT REAGENT KIT
- K781533 — SMA/GGT
- K780099 — ULTRAZYME PLUS GT
- K760711 — REAGENT SYSTEM (NO. SC 135)
- K760366 — REAGENT, Y-GT MAX-PACK
- K760346 — ASSAY FOR GAMMA GLUTAMYLTRANSFERASE
- K760025 — ULTRAZYME GT
Data sourced from openFDA. This site is unofficial and independent of the FDA.