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FDA 510(k)

NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software

K-Number: K193167 · 2019-12-11

ApplicantLuminex Molecular Diagnostics, Inc.
Decision Date2019-12-11
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software is a medical device manufactured by Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-12-11 under approval number K193167. 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 Files, SYNCT Software?

NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software is a medical device that received FDA 510(k) clearance on 2019-12-11. It is manufactured by Luminex Molecular Diagnostics, Inc.. The 510(k) number is K193167.

When was NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software approved by the FDA?

NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software received FDA 510(k) clearance on 2019-12-11, under approval number K193167.

What company makes NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software?

NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software is manufactured by Luminex Molecular Diagnostics, Inc..

What is the FDA product code for NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software?

The FDA product code for NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software is OCC.

Related Clinical Trials

NCT06878768 Translational Research GRICS-CineCardiac COMPLETED

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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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