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510(k) K020920

COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE by Cozart Bioscience , Ltd. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2002
Date Received
March 21, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
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)
  • K011131 — METHADONE MICROPLATE EIA URINE APPLICATION (July 31, 2001)

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