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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, Amphetamine
510(k) Number K052882
Device Name FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE
Applicant
Tianjin New Bay Bioresearch Co., Ltd.
3108 Avenida Olmeda
Carlsbad,  CA  92009
Applicant Contact RODRIGO BERLIE
Correspondent
Tianjin New Bay Bioresearch Co., Ltd.
3108 Avenida Olmeda
Carlsbad,  CA  92009
Correspondent Contact RODRIGO BERLIE
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JXM   JXN   LCM   LDJ   LFH  
Date Received10/12/2005
Decision Date 02/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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