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510(k) K240627

LIAISON PLEX Yeast Blood Culture Assay by Luminex Corporation — Product Code PEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2024
Date Received
March 6, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fungal Organisms, Nucleic Acid-Based Assay
Device Class
Class II
Regulation Number
866.3365
Review Panel
MI
Submission Type

A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.

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Other clearances for product code PEO

  • K182690 — ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel (December 21, 2018)