Home / 510(k) Clearances / K905096

510(k) K905096

GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 by Amresco, Inc. — Product Code JQB

K905096 is an FDA 510(k) premarket notification submitted by Amresco, Inc. for the device "GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138". The FDA issued a decision of Substantially Equivalent on November 28, 1990. The device falls under product code JQB (Kinetic Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Amresco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1990
Date Received
November 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kinetic Method, Gamma-Glutamyl Transpeptidase
Device Class
Class I
Regulation Number
862.1360
Review Panel
CH
Submission Type

Other clearances by Amresco, Inc.

  • K905618 — GGT REAGENT (February 26, 1991)
  • K904468 — DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 (January 17, 1991)
  • K905684 — ALKALINE PHOSPHATASE (December 28, 1990)
  • K905544 — MAGNESIUM REAGENT (December 27, 1990)
  • K905284 — HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 (December 11, 1990)
  • K904004 — AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 (December 11, 1990)
  • K904381 — DIAZO COLORIMENTRY DIRECT BILIRUBIN (October 12, 1990)
  • K903775 — CREATINE PHOSPHOKINASE (October 4, 1990)
  • K903829 — AST REAGENT (September 25, 1990)
  • K904007 — BICARBONATE REAGENTS AMRESCO PRODUCT #4326020 (September 13, 1990)

Other clearances for product code JQB

  • K974000 — Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 (November 4, 1997)
  • K973157 — LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET (October 10, 1997)
  • K971466 — SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) (May 6, 1997)
  • K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES (January 13, 1997)
  • K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASE (January 10, 1997)
  • K955770 — GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM (September 9, 1996)
  • K945800 — Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 (June 9, 1995)
  • K946192 — HICHEM Y-GT REAGENT KIT (May 2, 1995)
  • K942962 — GGT QVET (December 7, 1994)
  • K935984 — GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 (July 20, 1994)

FDA data resources