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FDA 510(k)

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR

K-Number: K163336 · 2016-12-15

ApplicantLuminex Molecular Diagnostics, Inc.
Decision Date2016-12-15
Product CodeNUA
Advisory CommitteeIM
DecisionUnknown

Device Summary

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR 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 2016-12-15 under 510(k) number K163336. The device is classified under product code NUA. It was reviewed by the IM advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR?

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K163336.

When did xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR receive FDA 510(k) clearance?

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR received FDA 510(k) clearance on 2016-12-15, under 510(k) number K163336.

Who is the listed applicant for xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR?

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 Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR?

The FDA product code for xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR is NUA.

Related Clinical Trials

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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: NUA)

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.

K163347xTAG Cystic Fibrosis 39 Kit v2Luminex Molecular Diagnostics, 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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