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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 K061617
Device Name FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST
Applicant
Tianjin New Bay Bioresearch Co., Ltd.
3108 Avenida Olmeda
Carlsbad,  CA  92009
Applicant Contact RODRIGO BERTIE
Correspondent
Tianjin New Bay Bioresearch Co., Ltd.
3108 Avenida Olmeda
Carlsbad,  CA  92009
Correspondent Contact RODRIGO BERTIE
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJG   DJR   DJS   JXM  
JXN   LCM   LDJ   LFG  
Date Received06/09/2006
Decision Date 11/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
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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