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510(k) K905649

GAMMA-GLUTAMYL TRANSFERASE DETERMINATION by Biochemical Trade, Inc. — Product Code JQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1991
Date Received
December 18, 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

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  • K905790 — TOTAL PROTEIN REAGENT SET (February 21, 1991)
  • K905650 — KINETIC ALKALINE PHOSPHATASE DETERMINATION (February 13, 1991)
  • K905619 — CREATININE (RATE) REAGENT SET (February 13, 1991)
  • K905651 — KINETIC AMYLASE DETERMINATION (January 31, 1991)
  • K905588 — CREATINE KINASE UV REAGENT SET (January 17, 1991)
  • K871547 — ULTRA-VIOLET BUN REAGENT KIT (RATE) (June 22, 1987)

Other clearances for product code JQB

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  • 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)