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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Specific Control Materials
510(k) Number K062942
Device Name QUANTIMETRIX NICOSURE COTININE URINE CONTROL
Applicant
Quantimetrix Corp.
2005 Manhattan Beach Blvd.
Redondo Beach,  CA  90278
Applicant Contact BERNICE NAVARRO
Correspondent
Quantimetrix Corp.
2005 Manhattan Beach Blvd.
Redondo Beach,  CA  90278
Correspondent Contact BERNICE NAVARRO
Regulation Number862.3280
Classification Product Code
LAS  
Date Received09/28/2006
Decision Date 10/30/2006
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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