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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 K233373
Device Name Flowflex® Plus COVID-19 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 Received10/02/2023
Decision Date 04/19/2024
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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