K243490
- 510(k) number
- K243490
- Device name
- LIAISON PLEX Gram-Positive Blood Culture Assay
- Applicant
- Luminex Corporation IL · US
- Product code
- PAM — Gram-Positive Bacteria And Their Resistance Markers
- Decision date
- 2025-06-06
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K243490.pdf
Official FDA record: K243490
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.