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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 Jan 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 17 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 10, 1997
Date Received
Dec 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
510(k) Exempt

Other clearances by Derma Media Lab., Inc.

  • K970664 — GLUCOSE REAGENT (Aug 1, 1997)
  • K971309 — UREA (Aug 1, 1997)
  • K971072 — CHOLESTEROL REAGENT (Jun 20, 1997)
  • K971005 — TRIGLYCERIDES (Apr 21, 1997)
  • K970867 — URIC ACID REAGENT (Apr 21, 1997)
  • K964915 — MAGNESIUM (Mar 26, 1997)
  • K964913 — IRON REAGENT (Feb 20, 1997)
  • K965134 — ALT/SGPT (Feb 18, 1997)
  • K964914 — ALKALINE PHOSPHATASE (Feb 4, 1997)
  • K965126 — AST/SGOT (Jan 17, 1997)

Other clearances for product code JQB

  • K974000 — Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 (Nov 4, 1997)
  • K973157 — LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET (Oct 10, 1997)
  • K971466 — SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) (May 6, 1997)
  • K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES (Jan 13, 1997)
  • K955770 — GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM (Sep 9, 1996)
  • K945800 — Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 (Jun 9, 1995)
  • K946192 — HICHEM Y-GT REAGENT KIT (May 2, 1995)
  • K942962 — GGT QVET (Dec 7, 1994)
  • K935984 — GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 (Jul 20, 1994)
  • K941315 — STANBIO Y-GT (LIQUICOLOR) TEST SET (Jul 14, 1994)

FDA data resources

Source: FDA 510(k) database entry for K964916. Report a data issue: hello@regdatalab.com.