NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)— 510(k) K231758

Name: FDA 510(k) clearance K231758
Creator: U.S. Food and Drug Administration
Published: 2024-03-11

Substantially Equivalent

Luminex Molecular Diagnostics, Inc.

FDA 510(k) clearance K231758 for NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2), Substantially Equivalent on 2024-03-11. Applicant: Luminex Molecular Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Luminex Molecular Diagnostics, Inc.
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2023-06-16
Decision date: 2024-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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