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510(k) K102346

RANDOX DIGOXIN ASSAY by Randox Laboratories, Ltd. — Product Code KXT

K102346 is an FDA 510(k) premarket notification submitted by Randox Laboratories, Ltd. for the device "RANDOX DIGOXIN ASSAY". The FDA issued a decision of Substantially Equivalent on October 14, 2011. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. Randox Laboratories, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2011
Date Received
August 19, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Digoxin
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Randox Laboratories, Ltd.

  • DEN240035 — ConcizuTrace™ ELISA (May 22, 2025)
  • K230890 — ISE Electrodes (September 8, 2023)
  • K182042 — Randox Calcium (Ca) (October 23, 2018)
  • K162200 — Randox RX Daytona Plus Magnesium (MG) (April 28, 2017)
  • K152085 — Liquid CO2-2 (LCO2-2) (February 24, 2016)
  • K153435 — Direct HDL Cholesterol (HDL) (January 8, 2016)
  • K150654 — Cholesterol (September 29, 2015)
  • K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE ( (January 9, 2014)
  • K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR (November 21, 2013)
  • K132156 — RANDOX CSF CONTROLS LEVELS 2 AND 3 (October 23, 2013)

Other clearances for product code KXT

  • K193397 — ADVIA Centaur® Digoxin assay (July 16, 2021)
  • K153301 — Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II (April 8, 2016)
  • K093441 — DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 (April 7, 2010)
  • K082953 — ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-0 (December 22, 2008)
  • K061249 — AXSYM DIGOXIN III (June 2, 2006)
  • K033007 — BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM (November 14, 2003)
  • K023058 — QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM (October 24, 2002)
  • K012301 — IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) (September 19, 2001)
  • K011302 — RANDOX DIGOXIN (July 2, 2001)
  • K011920 — EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 (July 2, 2001)

FDA data resources