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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K060417
Device Name MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
Applicant
Quantimetrix Corp.
2005 Manhattan Beach Blvd.
Redondo Beach,  CA  90278
Applicant Contact JACK COGGAN
Correspondent
Quantimetrix Corp.
2005 Manhattan Beach Blvd.
Redondo Beach,  CA  90278
Correspondent Contact JACK COGGAN
Regulation Number862.3280
Classification Product Code
DIF  
Date Received02/17/2006
Decision Date 03/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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