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510(k) K803089

GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) by Environmental Chemical Specialties — Product Code JPZ

K803089 is an FDA 510(k) premarket notification submitted by Environmental Chemical Specialties for the device "GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT)". The FDA issued a decision of Substantially Equivalent on January 2, 1981. The device falls under product code JPZ (Colorimetric Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Environmental Chemical Specialties has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1981
Date Received
December 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Gamma-Glutamyl Transpeptidase
Device Class
Class I
Regulation Number
862.1360
Review Panel
CH
Submission Type

Other clearances by Environmental Chemical Specialties

  • K812635 — ANEMIA CONTROL (October 2, 1981)
  • K811810 — URIC ACID TEST (July 15, 1981)
  • K811809 — ANTI-ARRHYTHMIC CONTROL LEVELS I & II (July 10, 1981)
  • K811811 — TDM ANTI-CONVULSANT CONTROL LEVELS I-II (July 10, 1981)
  • K792377 — CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL (September 26, 1980)
  • K801854 — SPINAL FLUID CONTROL(HUMAN) (September 16, 1980)
  • K801061 — TOTAL PROTEIN TEST (July 21, 1980)
  • K792374 — QUANTITATIVE CONTROL URINE I (HUMAN) (December 6, 1979)
  • K792376 — QUANTITATIVE CONTROL URINE II (HUMAN) (December 6, 1979)
  • K792375 — ELEVATED LIPID CONTROL (December 6, 1979)

Other clearances for product code JPZ

  • K020486 — CARESIDE GGT (July 1, 2002)
  • K961919 — DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE (July 1, 1996)
  • K923509 — GAMMA-GT (December 3, 1992)
  • K923091 — KING DIAGNOSTICS GAMMA GT REAGENT (September 9, 1992)
  • K905618 — GGT REAGENT (February 26, 1991)
  • K903304 — ROCHE COBAS READY GGT REAGENT (October 12, 1990)
  • K901090 — ELITECH GAMMA GT TEST KIT (March 29, 1990)
  • K895984 — WAKO(TM) AUTOKIT GAMMA-GT (November 8, 1989)
  • K881239 — GAMMA GLUTAMYL TRANSFERASE REAGENT SET (May 31, 1988)
  • K874903 — MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) (February 11, 1988)

FDA data resources