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510(k) K946192

HICHEM Y-GT REAGENT KIT by Hichem Diagnostics — Product Code JQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1995
Date Received
December 20, 1994
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 Hichem Diagnostics

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  • K953863 — HICHEM ISE STANDARDS KIT 70011 (September 6, 1995)
  • K953860 — HICHEM ISE DILUENT KIT 70008 (September 6, 1995)
  • K953862 — HICHEM ISEKCI SOLUTION KIT 70010 (September 6, 1995)
  • K951751 — HICHEM AST REAGENT KIT (August 2, 1995)
  • K946022 — HICHEM LDH/L REAGENT KIT (February 23, 1995)
  • K941433 — HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH (August 2, 1994)
  • K925551 — HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 (April 20, 1993)

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)
  • K942962 — GGT QVET (December 7, 1994)
  • K935984 — GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 (July 20, 1994)
  • K941315 — STANBIO Y-GT (LIQUICOLOR) TEST SET (July 14, 1994)