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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 K122064
Device Name FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE
Applicant
Tianjin New Bay Bioresearch Co., Ltd.
4455 Murphy Canyon Rd., Suite 204
San Diego,  CA  92123
Applicant Contact Roger De Bock
Correspondent
Tianjin New Bay Bioresearch Co., Ltd.
4455 Murphy Canyon Rd., Suite 204
San Diego,  CA  92123
Correspondent Contact Roger De Bock
Regulation Number862.3650
Classification Product Code
DJG  
Date Received07/13/2012
Decision Date 05/07/2013
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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