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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK130275
Test Name Kassac Laboratories Multi (MDMA and OPI) Drug Test Cup  {Urine} (Cup Format)
Manufacturer NameTianjin New Bay Bioresearch Co., Ltd.
Consumer Information Phone Number(212)235-5181
Test TypeOpiates
Effective Date06/19/2014
Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K130275
Device Name QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
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  
Subsequent Product Code
LAF  
Date Received02/04/2013
Decision Date 09/26/2013
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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