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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K241188
Device Name Acucy® Influenza A&B Test with the Acucy® 2 System
Applicant
SEKISUI Diagnostics, LLC
6659 Top Gun St.
San Diego,  CA  92121
Applicant Contact Craig Jolicoeur
Correspondent
SEKISUI Diagnostics, LLC
6659 Top Gun St.
San Diego,  CA  92121
Correspondent Contact Jason Bilobram
Regulation Number866.3328
Classification Product Code
PSZ  
Subsequent Product Code
JJE  
Date Received04/29/2024
Decision Date 04/18/2025
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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