XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)— 510(k) K093420

Substantially Equivalent

Luminex Molecular Diagnostics, Inc.

FDA 510(k) clearance K093420 for XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254), Substantially Equivalent on 2010-08-26. Applicant: Luminex Molecular Diagnostics, Inc..

Clearance details

Applicant: Luminex Molecular Diagnostics, Inc.
Product code: Code NTI
Advisory panel: Clinical Toxicology
Date received: 2009-11-03
Decision date: 2010-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

Download summary PDF View on FDA.gov ↗

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