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510(k) K860723

G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT by Trace Scientific , Ltd. — Product Code JPZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1986
Date Received
February 26, 1986
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

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  • K952488 — TRACE COBAS MIRA RANGE (October 13, 1995)
  • K932713 — TRACE TRANSFERRIN REAGENT (September 30, 1993)
  • K923322 — TRACE ALBUMIN-MR REAGENT (September 11, 1992)
  • K914731 — TRACE GAMMA GT-SS REAGENT (November 19, 1991)
  • K911866 — TRACE TOTAL/DIRECT BILIRUBIN REAGENT (July 17, 1991)

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)