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510(k) K881239

GAMMA GLUTAMYL TRANSFERASE REAGENT SET by Tech-Neal Scientific, Inc. — Product Code JPZ

K881239 is an FDA 510(k) premarket notification submitted by Tech-Neal Scientific, Inc. for the device "GAMMA GLUTAMYL TRANSFERASE REAGENT SET". The FDA issued a decision of Substantially Equivalent on May 31, 1988. The device falls under product code JPZ (Colorimetric Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Tech-Neal Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1988
Date Received
March 22, 1988
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 Tech-Neal Scientific, Inc.

  • K882256 — MAGNESIUM REAGENT SET (August 8, 1988)
  • K882459 — DIAZO, COLORIMETRIC BILIRUBIN (August 2, 1988)
  • K881241 — TOTAL BILIRUBIN REAGENT (May 27, 1988)
  • K881237 — CREATINE KINASE (CK) REAGENT SET (April 28, 1988)
  • K881240 — CHLORIDE REAGENT SET (April 28, 1988)
  • K880237 — CHOLESTEROL (April 28, 1988)
  • K880277 — URIC ACID REAGENT SET (April 18, 1988)
  • K880843 — CREATININE REAGENT SET (KINETIC) (April 5, 1988)
  • K880842 — LDH-L REAGENT SET (April 5, 1988)
  • K880845 — CALCIUM REAGENT SET (April 5, 1988)

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)
  • K874903 — MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) (February 11, 1988)
  • K871979 — GAMMA GLUTAMYLTRANSFERASE REAGENT (June 11, 1987)

FDA data resources