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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, Opiates
510(k) Number K042990
Device Name FOR SURE ONE STEP BUPRENORPHINE TEST STRIP
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 Number862.3650
Classification Product Code
DJG  
Date Received10/29/2004
Decision Date 05/10/2005
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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