K242613
- 510(k) number
- K242613
- Device name
- NxTAG® Respiratory Pathogen Panel
- Applicant
- Luminex Molecular Diagnostics, Inc. CA
- Product code
- OCC — Respiratory Virus Panel Nucleic Acid Assay System
- Decision date
- 2024-10-02
- Date received
- 2024-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K242613
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.