K231758
- 510(k) number
- K231758
- Device name
- NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
- Applicant
- Luminex Molecular Diagnostics, Inc. CA
- Product code
- QOF — Multi-Target Respiratory Specimen Nucleic Acid Test
- Decision date
- 2024-03-11
- Date received
- 2023-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K231758.pdf
Official FDA record: K231758
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.