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510(k) K050179

RANDOX BENZODIAZEPINE CLASS ASSAY by Randox Laboratories, Ltd. — Product Code JXM

K050179 is an FDA 510(k) premarket notification submitted by Randox Laboratories, Ltd. for the device "RANDOX BENZODIAZEPINE CLASS ASSAY". The FDA issued a decision of Substantially Equivalent on May 17, 2005. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. Randox Laboratories, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2005
Date Received
January 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Benzodiazepine
Device Class
Class II
Regulation Number
862.3170
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 JXM

  • K243498 — Alinity c Benzodiazepines Reagent Kit (December 11, 2024)
  • K221765 — ONLINE DAT Benzodiazepines II (December 23, 2022)
  • K190968 — CEDIA Benzodiazepine Assay (December 9, 2019)
  • K173963 — DRI Benzodiazepine Assay (February 21, 2018)
  • K163590 — Psychemedics Microplate EIA for Benzodiazepines in Hair (September 15, 2017)
  • K163704 — Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card (August 2, 2017)
  • K153597 — Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (May 23, 2016)
  • K151771 — Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Cal (January 5, 2016)
  • K151642 — Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (August 13, 2015)
  • K150356 — Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (May 13, 2015)

FDA data resources