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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Tricyclic Antidepressant Drugs
510(k) Number K072062
Device Name UCP MULTIPLE DRUG SCREEN TEST CUPS
Applicant
Ucp Biosciences, Inc.
1445 Koll Cir., Suite 111
San Jose,  CA  95112
Applicant Contact NANCY CHEN
Correspondent
Ucp Biosciences, Inc.
1445 Koll Cir., Suite 111
San Jose,  CA  95112
Correspondent Contact NANCY CHEN
Regulation Number862.3910
Classification Product Code
LFG  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
DKZ   JXM   JXN   LCM   LDJ  
Date Received07/27/2007
Decision Date 09/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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