FDA.reportPublic FDA data

510(k) K220026

Device
Genomadix Cube CYP2C19 System
Applicant
Genomadix, Inc.
510(k) number
K220026
Product code
NTI
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-21
Date received
2022-01-05
Regulation
862.3360
Classification name
Drug Metabolizing Enzyme Genotyping Systems
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Amanda Dwyer
Address
340 Legget Dr., Suite 180 Kanata (Ottawa) CA

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NTI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K170492xTAG CYP2D6 Kit v3Luminex Molecular Diagnostics, Inc.2017-08-11
K131565XTAG CYP2C19 KIT V3Luminex Molecular Diagnostics, Inc.2013-09-11
K123891SPARTAN RX CYP2C19 TEST SYSTEMSpartan Bioscience, Inc.2013-08-12
K130189XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)Luminex Molecular Diagnostics, Inc.2013-05-21
K120466VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)Nanosphere, Inc.2012-11-06
K101683INFINITI CYP2C19 ASSAYAutogenomics, Incorporated2010-10-25
K093420XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)Luminex Molecular Diagnostics, Inc.2010-08-26
K051824INVADER UGT1A1 MOLECULAR ASSAYThird Wave Technologies, Inc.2005-08-18
K043576ROCHE AMPLICHIP CYP450 TESTRoche Molecular Systems, Inc.2005-01-10
DEN040011AMPLICHIP CYP450 TEST, MODEL 04381866190Roche Molecular Systems, Inc.2004-12-23