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510(k) K961919

DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE by Data Medical Associates, Inc. — Product Code JPZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1996
Date Received
May 17, 1996
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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Other clearances for product code JPZ

  • K020486 — CARESIDE GGT (July 1, 2002)
  • 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)
  • K871979 — GAMMA GLUTAMYLTRANSFERASE REAGENT (June 11, 1987)