XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)— 510(k) K130189

Substantially Equivalent

Luminex Molecular Diagnostics, Inc.

FDA 510(k) clearance K130189 for XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE), Substantially Equivalent on 2013-05-21. Applicant: Luminex Molecular Diagnostics, Inc..

Clearance details

Applicant: Luminex Molecular Diagnostics, Inc.
Product code: Code NTI
Advisory panel: Clinical Toxicology
Date received: 2013-01-25
Decision date: 2013-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

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