COZART EIA OPIATES ORAL FLUID KIT


Device Classification Name

cholinesterase test paper

510(k) Number K024339
Device Name COZART EIA OPIATES ORAL FLUID KIT
Original Applicant
COZART BIOSCIENCE LTD.
45 milton park
abingdon
oxfordshire ox14 4ru, 

GB

ox14 4ru

Original Contact roberto liddi
Regulation Number 862.3240
Classification Product Code
DIG  
Date Received 12/27/2002
Decision Date 04/07/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No