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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fungal organisms, nucleic acid-based assay
510(k) Number K240627
Device Name LIAISON PLEX Yeast Blood Culture Assay
Luminex Corporation
4088 Commercial Ave.
Northbrook,  IL  60062
Applicant Contact Sarah Herzog
Luminex Corporation
4088 Commercial Ave.
Northbrook,  IL  60062
Correspondent Contact Sarah Herzog
Regulation Number866.3365
Classification Product Code
Subsequent Product Code
Date Received03/06/2024
Decision Date 06/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No