K170492

Substantially Equivalent

xTAG CYP2D6 Kit v3

Applicant: Luminex Molecular Diagnostics, Inc.
Product 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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.