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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 K242526
Device Name Visby Medical Respiratory Health Test
Applicant
Visby Medical, Inc.
3010 North First Street
San Jose,  CA  95134
Applicant Contact Jennifer Albrecht
Correspondent
Visby Medical, Inc.
3010 North First Street
San Jose,  CA  95134
Correspondent Contact Jennifer Albrecht
Regulation Number866.3981
Classification Product Code
QOF  
Date Received08/26/2024
Decision Date 02/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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