SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST


Device Classification Name

enzyme immunoassay, barbiturate

510(k) Number K000522
Device Name SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST
Original Applicant
DRUG DETECTION DEVICES, LTD.
6820 meadowridge court
suite a-7
alpharetta, 
GA 
30005

Original Contact patrick beentjes
Regulation Number 862.3150
Classification Product Code
DIS  
Date Received 02/16/2000
Decision Date 04/18/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No