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510(k) K941315

STANBIO Y-GT (LIQUICOLOR) TEST SET by Stanbio Laboratory — Product Code JQB

K941315 is an FDA 510(k) premarket notification submitted by Stanbio Laboratory for the device "STANBIO Y-GT (LIQUICOLOR) TEST SET". The FDA issued a decision of Substantially Equivalent on Jul 14, 1994. The device falls under product code JQB (Kinetic Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Stanbio Laboratory has 46 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 14, 1994
Date Received
Mar 18, 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
510(k) Exempt

Other clearances by Stanbio Laboratory

  • K090093 — STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM (Jun 10, 2009)
  • K081719 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (Jul 18, 2008)
  • K050266 — DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR (Jun 30, 2005)
  • K050283 — CREATININE LIQUICOLOR (Jun 30, 2005)
  • K042169 — STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER (Mar 14, 2005)
  • K041155 — WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY (Oct 14, 2004)
  • K032936 — DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL… (Mar 12, 2004)
  • K032932 — DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR (Mar 10, 2004)
  • K032482 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (Oct 24, 2003)
  • K020378 — QUPID PLUS E.R. (Jun 21, 2002)

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)
  • K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASE (Jan 10, 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)

FDA data resources

Source: FDA 510(k) database entry for K941315. Report a data issue: hello@regdatalab.com.