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510(k) K964916

GAMMA-GLUTAMYL TRANSPEPTIDASE by Derma Media Lab., Inc. — Product Code JQB

K964916 is an FDA 510(k) premarket notification submitted by Derma Media Lab., Inc. for the device "GAMMA-GLUTAMYL TRANSPEPTIDASE". The FDA issued a decision of Substantially Equivalent on January 10, 1997. The device falls under product code JQB (Kinetic Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Derma Media Lab., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1997
Date Received
December 9, 1996
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 Derma Media Lab., Inc.

  • K970664 — GLUCOSE REAGENT (August 1, 1997)
  • K971309 — UREA (August 1, 1997)
  • K971072 — CHOLESTEROL REAGENT (June 20, 1997)
  • K970867 — URIC ACID REAGENT (April 21, 1997)
  • K971005 — TRIGLYCERIDES (April 21, 1997)
  • K964915 — MAGNESIUM (March 26, 1997)
  • K964913 — IRON REAGENT (February 20, 1997)
  • K965134 — ALT/SGPT (February 18, 1997)
  • K964914 — ALKALINE PHOSPHATASE (February 4, 1997)
  • K965126 — AST/SGOT (January 17, 1997)

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)
  • 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)
  • K941315 — STANBIO Y-GT (LIQUICOLOR) TEST SET (July 14, 1994)

FDA data resources