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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, Phencyclidine
510(k) Number K000402
Device Name SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
Applicant
Drug Detection Devices, Ltd.
6820 Meadowridge Ct.
Suite A-7
Alpharetta,  GA  30005
Applicant Contact PATRICK BEENTJES
Correspondent
Drug Detection Devices, Ltd.
6820 Meadowridge Ct.
Suite A-7
Alpharetta,  GA  30005
Correspondent Contact PATRICK BEENTJES
Classification Product Code
LCM  
Date Received02/07/2000
Decision Date 04/18/2000
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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