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510(k) K011131

METHADONE MICROPLATE EIA URINE APPLICATION by Cozart Bioscience , Ltd. — Product Code DJR

K011131 is an FDA 510(k) premarket notification submitted by Cozart Bioscience , Ltd. for the device "METHADONE MICROPLATE EIA URINE APPLICATION". The FDA issued a decision of Substantially Equivalent on July 31, 2001. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. Cozart Bioscience , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2001
Date Received
April 13, 2001
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 Cozart Bioscience , Ltd.

  • K033743 — COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT (June 3, 2004)
  • K021944 — COZART EIA COTININE URINE KIT (May 14, 2003)
  • K030234 — COZART EIA COCAINE ORAL FLIUD KIT (April 28, 2003)
  • K024339 — COZART EIA OPIATES ORAL FLUID KIT (April 7, 2003)
  • K020920 — COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE (November 5, 2002)

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)
  • K092272 — RANDOX METHADONE ASSAY (November 18, 2010)
  • K092258 — RANDOX METABOLITE (EDDP) ASSAY (November 9, 2010)

FDA data resources