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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 K192719
Device Name Osom Ultra Plus Flu A&B Test Kit
Applicant
Sekisui Diagnostics, LLC
6659 Top Gun St.
San Diegi,  CA  92121
Applicant Contact Nisha Li
Correspondent
Sekisui Diagnostics, LLC
6659 Top Gun St.
San Diegi,  CA  92121
Correspondent Contact Nisha Li
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received09/26/2019
Decision Date 04/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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