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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 K220407
Device Name Visby Medical Sexual Health Test
Visby Medical
3010 N 1st Street
San Jose,  CA  95134
Applicant Contact Beth Lingenfelter
Visby Medical
3010 N 1st Street
San Jose,  CA  95134
Correspondent Contact Beth Lingenfelter
Regulation Number866.3393
Classification Product Code
Subsequent Product Codes
Date Received02/14/2022
Decision Date 03/07/2023
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