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FDA 510(k)

NxTAG® Respiratory Pathogen Panel

K-Number: K242613 · 2024-10-02

ApplicantLuminex Molecular Diagnostics, Inc.
Decision Date2024-10-02
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NxTAG® Respiratory Pathogen Panel is a medical device manufactured by Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-10-02 under approval number K242613. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NxTAG® Respiratory Pathogen Panel?

NxTAG® Respiratory Pathogen Panel is a medical device that received FDA 510(k) clearance on 2024-10-02. It is manufactured by Luminex Molecular Diagnostics, Inc.. The 510(k) number is K242613.

When was NxTAG® Respiratory Pathogen Panel approved by the FDA?

NxTAG® Respiratory Pathogen Panel received FDA 510(k) clearance on 2024-10-02, under approval number K242613.

What company makes NxTAG® Respiratory Pathogen Panel?

NxTAG® Respiratory Pathogen Panel is manufactured by Luminex Molecular Diagnostics, Inc..

What is the FDA product code for NxTAG® Respiratory Pathogen Panel?

The FDA product code for NxTAG® Respiratory Pathogen Panel is OCC.

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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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