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

Drug Metabolizing Enzyme Genotyping Systems

LUMINEX MOLECULAR DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Luminex Molecular Diagnostics, Inc. with the FDA for Xtag Cyp2d6 Kit V3, Model I030c0300 (96 Tests/kit), Tdas Cyp2d6 Software (2030-0254).

Pre-market Notification Details

• Device ID: K093420
• 510k Number: K093420
• Device Name: XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)
• Classification: Drug Metabolizing Enzyme Genotyping Systems
• Applicant: LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. Toronto, Ontario, CA M5g 1y8
• Contact: Gloria Lee
• Correspondent: Gloria Lee; LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. Toronto, Ontario, CA M5g 1y8
• Product Code: NTI
• CFR Regulation Number: 862.3360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-11-03
• Decision Date: 2010-08-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840487101025	K093420	000
00840487100134	K093420	000