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510(k) K243013

LIAISON PLEX Gram-Negative Blood Culture Assay by Luminex Corporation — Product Code PEN

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.

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