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510(k) K901090

ELITECH GAMMA GT TEST KIT by Elite Technology, Inc. — Product Code JPZ

K901090 is an FDA 510(k) premarket notification submitted by Elite Technology, Inc. for the device "ELITECH GAMMA GT TEST KIT". The FDA issued a decision of Substantially Equivalent on March 29, 1990. The device falls under product code JPZ (Colorimetric Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Elite Technology, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1990
Date Received
March 7, 1990
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 Elite Technology, Inc.

  • K900733 — PROTEIN TEST FOR URINE AND CSF (July 10, 1990)
  • K901001 — URIC ACID TEST KIT (May 23, 1990)
  • K895951 — CHOLESTEROL TEST KIT (February 16, 1990)
  • K895952 — TRIGLYCERIDES TEST KIT (January 11, 1990)

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)
  • 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)
  • K871979 — GAMMA GLUTAMYLTRANSFERASE REAGENT (June 11, 1987)

FDA data resources