K243013
- 510(k) number
- K243013
- Device name
- LIAISON PLEX Gram-Negative Blood Culture Assay
- Applicant
- Luminex Corporation IL · US
- Product code
- PEN — Gram-Negative Bacteria And Associated Resistance Mar
- Decision date
- 2025-04-18
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K243013.pdf
Official FDA record: K243013
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.