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510(k) K820233

ULTRAZYME PLUS GAMMA GT(65055-65056) by Harleco — Product Code JQB

K820233 is an FDA 510(k) premarket notification submitted by Harleco for the device "ULTRAZYME PLUS GAMMA GT(65055-65056)". The FDA issued a decision of Substantially Equivalent on February 12, 1982. The device falls under product code JQB (Kinetic Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Harleco has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1982
Date Received
January 28, 1982
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 Harleco

  • K813427 — ULTRACHEM GLUC-DH (December 31, 1981)
  • K813039 — ULTRACHEM E-CHOL, ITEM #65025 (November 10, 1981)
  • K813044 — ULTRACHEM ALB, ITEM #64970 (November 10, 1981)
  • K813043 — ULTRACHEM CREA ITEM #64972 (November 10, 1981)
  • K813042 — ULTRACHEM GLUC-DH SET, ITEM #65048 (November 10, 1981)
  • K813041 — ULTRAZYME-GT, ITEM #64959 & 65032 (November 10, 1981)
  • K813038 — ULTRACHEM TP, ITEM #64974 (November 10, 1981)
  • K813040 — ULTRACHEM CA, ITEM #64975 (November 10, 1981)
  • K812594 — ULTRA ZYME PLUS AMYL #64982 & 65031 (October 2, 1981)
  • K812593 — ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 (October 2, 1981)

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