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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Barbiturate
510(k) Number K000522
Device Name SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST
Applicant
DRUG DETECTION DEVICES, LTD.
6820 MEADOWRIDGE COURT
SUITE A-7
ALPHARETTA,  GA  30005
Applicant Contact PATRICK BEENTJES
Correspondent
DRUG DETECTION DEVICES, LTD.
6820 MEADOWRIDGE COURT
SUITE A-7
ALPHARETTA,  GA  30005
Correspondent Contact PATRICK BEENTJES
Regulation Number862.3150
Classification Product Code
DIS  
Date Received02/16/2000
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
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