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 K251742
Device Name VELO Respiratory Test
Applicant
Lex Diagnostics Limited
Melbourn Science Park
Melbourn,  GB SG8 6EE
Applicant Contact Heather Danks
Correspondent
Lex Diagnostics Limited
Melbourn Science Park
Melbourn,  GB SG8 6EE
Correspondent Contact Joanne Channon
Regulation Number866.3981
Classification Product Code
QOF  
Date Received06/06/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-