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510(k) K871979

GAMMA GLUTAMYLTRANSFERASE REAGENT by Intersect Systems, Inc. — Product Code JPZ

K871979 is an FDA 510(k) premarket notification submitted by Intersect Systems, Inc. for the device "GAMMA GLUTAMYLTRANSFERASE REAGENT". The FDA issued a decision of Substantially Equivalent on June 11, 1987. The device falls under product code JPZ (Colorimetric Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Intersect Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1987
Date Received
May 22, 1987
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 Intersect Systems, Inc.

  • K021636 — ALBUMIN REAGENT (July 17, 2002)
  • K011972 — DIRECT BILIRUBIN REAGENT (August 27, 2001)
  • K011692 — HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT (July 25, 2001)
  • K003892 — TOTAL BILIRUBIN REAGENT (February 20, 2001)
  • K983937 — DUAL VIAL CREATININE REAGENT (January 6, 1999)
  • K974833 — CK-NAC REAGENT (February 13, 1998)
  • K941807 — INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT (September 14, 1994)
  • K932888 — INTERSECT SYSTEMS DIRECT AMYLASE REAGENT (January 31, 1994)
  • K934039 — INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET (November 16, 1993)
  • K932267 — ENZYMATIC CO2 REAGENT, MODIFICATION (September 24, 1993)

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