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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Metabolizing Enzyme Genotyping Systems
510(k) Number K130189
Device Name XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)
Applicant
Luminex Molecular Diagnostics, Inc.
439 University Ave.
Toronto, Ontario,  CA m5g 1y8
Applicant Contact LUBNA SYED
Correspondent
Luminex Molecular Diagnostics, Inc.
439 University Ave.
Toronto, Ontario,  CA m5g 1y8
Correspondent Contact LUBNA SYED
Regulation Number862.3360
Classification Product Code
NTI  
Date Received01/25/2013
Decision Date 05/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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