LIAISON PLEX Gram-Positive Blood Culture Assay— 510(k) K243490

Substantially Equivalent

Luminex Corporation

FDA 510(k) clearance K243490 for LIAISON PLEX Gram-Positive Blood Culture Assay, Substantially Equivalent on 2025-06-06. Applicant: Luminex Corporation.

Clearance details

Applicant: Luminex Corporation
Product code: Code PAM
Advisory panel: Microbiology
Date received: 2024-11-12
Decision date: 2025-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PAM

product code PAM

Death: 6
Malfunction: 598
Total: 604

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.