510(k) K243013
K243013 is an FDA 510(k) premarket notification submitted by Luminex Corporation for the device "LIAISON PLEX Gram-Negative Blood Culture Assay". The FDA issued a decision of Substantially Equivalent on April 18, 2025. The device falls under product code PEN (Gram-Negative Bacteria And Associated Resistance Markers), a Class II device regulated under 21 CFR 866.3365. Luminex Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 2025
- Date Received
- September 27, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gram-Negative Bacteria And Associated Resistance Markers
- Device Class
- Class II
- Regulation Number
- 866.3365
- Review Panel
- MI
- Submission Type
A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.