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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, Cocaine And Cocaine Metabolites
510(k) Number K050321
Device Name ONTRAK TESTCARD 9
Applicant
Varian, Inc.
25200 Commercentre Dr.
Lake Forest,  CA  92630
Applicant Contact LORNA GAMBOA
Correspondent
Varian, Inc.
25200 Commercentre Dr.
Lake Forest,  CA  92630
Correspondent Contact LORNA GAMBOA
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DIS   DJJ   DKZ   JXM   LAF  
LCM   LDJ   LFG  
Date Received02/09/2005
Decision Date 04/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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