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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-08-11 under 510(k) 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. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K170492.

When did xTAG CYP2D6 Kit v3 receive FDA 510(k) clearance?

xTAG CYP2D6 Kit v3 received FDA 510(k) clearance on 2017-08-11, under 510(k) number K170492.

Who is the listed applicant for xTAG CYP2D6 Kit v3?

The FDA 510(k) record lists Luminex Molecular Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for xTAG CYP2D6 Kit v3?

The FDA product code for xTAG CYP2D6 Kit v3 is NTI.

Other records listing Luminex Molecular Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242613NxTAG® Respiratory Pathogen PanelK231758NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)K193167NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareK191161xTAG Gastrointestinal Pathogen Panel (GPP)K191160xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)K183030xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

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Related Devices (Code: NTI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220026Genomadix Cube CYP2C19 SystemGenomadix, Inc.

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.

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