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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
510(k) Number K251501
Device Name Visby Medical Men's Sexual Health Test
Applicant
Visby Medical, Inc.
3010 N1st St.
San Jose,  CA  95134
Applicant Contact Jennifer Albrecht
Correspondent
Visby Medical, Inc.
3010 N1st St.
San Jose,  CA  95134
Correspondent Contact Jennifer Albrecht
Classification Product Code
QEP  
Date Received05/15/2025
Decision Date 10/01/2025
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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