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510(k) K092272

RANDOX METHADONE ASSAY by Randox Laboratories, Ltd. — Product Code DJR

K092272 is an FDA 510(k) premarket notification submitted by Randox Laboratories, Ltd. for the device "RANDOX METHADONE ASSAY". The FDA issued a decision of Substantially Equivalent on November 18, 2010. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. Randox Laboratories, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2010
Date Received
July 28, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Methadone
Device Class
Class II
Regulation Number
862.3620
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 DJR

  • K192433 — LZI Methadone II Enzyme Immunoassay (October 4, 2019)
  • K182779 — ARK EDDP Assay (November 21, 2018)
  • K170416 — LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 3 (June 26, 2017)
  • K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign D (August 17, 2016)
  • K152025 — AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (October 5, 2015)
  • K151395 — Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calib (July 24, 2015)
  • K151441 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (June 29, 2015)
  • K131232 — WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) (May 31, 2013)
  • K092258 — RANDOX METABOLITE (EDDP) ASSAY (November 9, 2010)
  • K092048 — ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP (April 19, 2010)

FDA data resources