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510(k) K021944

COZART EIA COTININE URINE KIT by Cozart Bioscience , Ltd. — Product Code MKU

K021944 is an FDA 510(k) premarket notification submitted by Cozart Bioscience , Ltd. for the device "COZART EIA COTININE URINE KIT". The FDA issued a decision of Substantially Equivalent on May 14, 2003. The device falls under product code MKU (Enzyme Immunoassay, Nicotine And Nicotine Metabolites), a Class I device regulated under 21 CFR 862.3220. Cozart Bioscience , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2003
Date Received
June 13, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Device Class
Class I
Regulation Number
862.3220
Review Panel
TX
Submission Type

Other clearances by Cozart Bioscience , Ltd.

  • K033743 — COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT (June 3, 2004)
  • 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)
  • K011131 — METHADONE MICROPLATE EIA URINE APPLICATION (July 31, 2001)

Other clearances for product code MKU

  • K192517 — Psychemedics Microplate EIA for Cotinine in Hair (April 22, 2020)
  • K192299 — LZI Cotinine II Enzyme Immunoassay (November 21, 2019)
  • K062565 — STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE (February 20, 2007)
  • K974534 — MICRO-PLATE COTININE EIA (May 18, 1998)
  • K974234 — MICRO-PLATE COTININE EIA (May 14, 1998)
  • K972481 — AUTO-LYTE COTININE EIA (October 21, 1997)

FDA data resources