Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Avenue
Northbrook,  IL  60062
Applicant Contact Tara Viviani
Correspondent
Luminex Corporation
4088 Commercial Avenue
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
-
-