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510(k) K033743

COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT by Cozart Bioscience , Ltd. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2004
Date Received
November 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Cozart Bioscience , Ltd.

  • 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)
  • K011131 — METHADONE MICROPLATE EIA URINE APPLICATION (July 31, 2001)

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