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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 K093420
Device Name XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)
Original Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 university ave.
toronto, ontario,  CA m5g 1y8
Original Contact gloria lee
Regulation Number862.3360
Classification Product Code
NTI  
Date Received11/18/2009
Decision Date 08/26/2010
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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