COZART EIA COTININE URINE KIT


Device Classification Name

enzyme immunoassasy, nocotine and nicotine metabolites

510(k) Number K021944
Device Name COZART EIA COTININE URINE KIT
Original Applicant
COZART BIOSCIENCE LTD.
45 milton park
abingdon
oxfordshire ox14 4ru, 

GB

ox14 4ru

Original Contact roberto liddi
Regulation Number 862.3220
Classification Product Code
MKU  
Date Received 06/13/2002
Decision Date 05/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No