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510(k) K024339

COZART EIA OPIATES ORAL FLUID KIT by Cozart Bioscience , Ltd. — Product Code DIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2003
Date Received
December 27, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cholinesterase Test Paper
Device Class
Class I
Regulation Number
862.3240
Review Panel
TX
Submission Type

Other clearances by Cozart Bioscience , Ltd.

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  • K021944 — COZART EIA COTININE URINE KIT (May 14, 2003)
  • K030234 — COZART EIA COCAINE ORAL FLIUD KIT (April 28, 2003)
  • K020920 — COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE (November 5, 2002)
  • K011131 — METHADONE MICROPLATE EIA URINE APPLICATION (July 31, 2001)