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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, Amphetamine
510(k) Number K033659
Device Name VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK
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 Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJG   LCM   LDJ  
LDM  
Date Received11/21/2003
Decision Date 01/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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