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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name over-the-counter covid-19 antigen test
510(k) Number K230828
Device Name Flowflex COVID-19 Antigen Home Test
Applicant
ACON Laboratories, Inc.
5850 Oberlin Drive, #340
San Diego,  CA  92121
Applicant Contact Qiyi Xie
Correspondent
MCRA, LLC
803 7th Street NW
Washington,  DC  20001
Correspondent Contact James E Mullally
Regulation Number866.3984
Classification Product Code
QYT  
Date Received03/27/2023
Decision Date 11/09/2023
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
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