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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 K051235
Device Name ON TRAK TESTCARD
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   DJJ   JXM   LAF  
LCM   LDJ   LFG  
Date Received05/13/2005
Decision Date 06/08/2005
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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