COZART EIA COCAINE ORAL FLIUD KIT


Device Classification Name

enzyme immunoassay, cocaine and cocaine metabolites

510(k) Number K030234
Device Name COZART EIA COCAINE ORAL FLIUD KIT
Original Applicant
COZART BIOSCIENCE LTD.
45 milton park
abingdon, oxon, 

GB

ox14 4ru

Original Contact roberto liddi
Regulation Number 862.3250
Classification Product Code
DIO  
Date Received 01/23/2003
Decision Date 04/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No