xTAG CYP2D6 Kit v3
K-Number: K170492 · 2017-08-11
ApplicantLuminex Molecular Diagnostics, Inc.
Decision Date2017-08-11
Product CodeNTI
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
xTAG CYP2D6 Kit v3 is a medical device manufactured by Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-08-11 under approval number K170492. The device is classified under product code NTI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the xTAG CYP2D6 Kit v3?
xTAG CYP2D6 Kit v3 is a medical device that received FDA 510(k) clearance on 2017-08-11. It is manufactured by Luminex Molecular Diagnostics, Inc.. The 510(k) number is K170492.
When was xTAG CYP2D6 Kit v3 approved by the FDA?
xTAG CYP2D6 Kit v3 received FDA 510(k) clearance on 2017-08-11, under approval number K170492.
What company makes xTAG CYP2D6 Kit v3?
xTAG CYP2D6 Kit v3 is manufactured by Luminex Molecular Diagnostics, Inc..
What is the FDA product code for xTAG CYP2D6 Kit v3?
The FDA product code for xTAG CYP2D6 Kit v3 is NTI.
Other Devices by Luminex Molecular Diagnostics, Inc.
K163347xTAG Cystic Fibrosis 39 Kit v2
K163336xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
K183030xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
K183023xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
K193167NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
K191161xTAG Gastrointestinal Pathogen Panel (GPP)
Related Devices (Code: NTI)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.