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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Groups, Streptococcus Spp.
510(k) Number K251697
Device Name Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
Applicant
ACON Laboratories, Inc.
9440 Carrol Park Dr.
San Diego,  CA  92121
Applicant Contact Catherine Shi
Correspondent
MCRA
803 7th St. NW
Washington,  DC  20001
Correspondent Contact James Mullally
Regulation Number866.3740
Classification Product Code
GTY  
Date Received06/02/2025
Decision Date 11/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
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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