xTAG CYP2D6 Kit v3— 510(k) K170492

Substantially Equivalent

Luminex Molecular Diagnostics, Inc.

FDA 510(k) clearance K170492 for xTAG CYP2D6 Kit v3, Substantially Equivalent on 2017-08-11. Applicant: Luminex Molecular Diagnostics, Inc..

Clearance details

Applicant: Luminex Molecular Diagnostics, Inc.
Product code: Code NTI
Advisory panel: Clinical Toxicology
Date received: 2017-02-17
Decision date: 2017-08-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, CA

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