FDA 510(k)

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

Numéro K : K193167 · 2019-12-11

DemandeurLuminex Molecular Diagnostics, Inc.

Date de décision2019-12-11

Code produitOCC

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software 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 2019-12-11 under 510(k) number K193167. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K193167.

When did NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software receive FDA 510(k) clearance?

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

Who is the listed applicant for NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software?

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 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.

Essais cliniques associés

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Source officielle

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