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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
510(k) Number K233410
Device Name LIAISON PLEX Respiratory Flex Assay
Applicant
Luminex Corporation
4088 Commercial Ave.
Northbrook,  IL  60062
Applicant Contact Tara Viviani
Correspondent
Luminex Corporation
4088 Commercial Ave.
Northbrook,  IL  60062
Correspondent Contact Tara Viviani
Regulation Number866.3981
Classification Product Code
QOF  
Subsequent Product Codes
NSU   OCC   OEM   OOU   OTG  
OZE   OZX   OZY   OZZ  
Date Received10/06/2023
Decision Date 03/01/2024
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
Predetermined Change
Control Plan Authorized		 No
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