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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 -8810
Applicant Contact LORNA GAMBOA
Correspondent
VARIAN INC
25200 COMMERCENTRE DR.
LAKE FOREST,  CA  92630 -8810
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
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