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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Respiratory Virus Antigen Detection Test
510(k) Number K251749
Device Name Flowflex Plus RSV + Flu A/B + COVID Home Test
Applicant
ACON Laboratories, Inc.
9440 Carroll Park Dr.
San Diego,  CA  92121
Applicant Contact Catherine Shi
Correspondent
MCRA
803 7th St. NW
Washington,  DC  20001
Correspondent Contact James Mullally
Classification Product Code
SCA  
Date Received06/06/2025
Decision Date 10/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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