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Document NumberK110515
Test Name American Screening Corporation, Inc., Multi-Drug Testing Cups  
Manufacturer NameUcp Biosciences, Inc.
Consumer Information Phone Number1(877)474-4097
Test TypeOpiates
Effective Date01/04/2013
Device Classification Name Enzyme Immunoassay, Barbiturate
510(k) Number K110515
Device Name UCP DRUG SCREENING TEST CUPS
Applicant
Ucp Biosciences, Inc.
1445 Koll Circle, Suite 111
San Jose,  CA  95112
Applicant Contact NANCY CHEN
Correspondent
Ucp Biosciences, Inc.
1445 Koll Circle, Suite 111
San Jose,  CA  95112
Correspondent Contact NANCY CHEN
Regulation Number862.3150
Classification Product Code
DIS  
Subsequent Product Codes
DIO   DJC   DJG   DJR   JXM  
LCM   LDJ   LFG  
Date Received02/23/2011
Decision Date 04/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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