LIAISON PLEX Gram-Negative Blood Culture Assay— 510(k) K243013
Substantially EquivalentLuminex Corporation
FDA 510(k) clearance K243013 for LIAISON PLEX Gram-Negative Blood Culture Assay, Substantially Equivalent on 2025-04-18. Applicant: Luminex Corporation.
Clearance details
- Applicant
- Luminex Corporation
- Product code
- Code PEN
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northbrook, IL, US
Adverse events under product code PEN
product code PEN- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.