XTAG CYP2C19 KIT V3— 510(k) K131565

Substantially Equivalent

Luminex Molecular Diagnostics, Inc.

FDA 510(k) clearance K131565 for XTAG CYP2C19 KIT V3, Substantially Equivalent on 2013-09-11. Applicant: Luminex Molecular Diagnostics, Inc..

Clearance details

Applicant: Luminex Molecular Diagnostics, Inc.
Product code: Code NTI
Advisory panel: Clinical Toxicology
Date received: 2013-05-30
Decision date: 2013-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

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