K240627
- 510(k) number
- K240627
- Device name
- LIAISON PLEX Yeast Blood Culture Assay
- Applicant
- Luminex Corporation IL · US
- Product code
- PEO — Fungal Organisms, Nucleic Acid-Based Assay
- Decision date
- 2024-06-04
- Date received
- 2024-03-06
- 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: K240627.pdf
Official FDA record: K240627
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.