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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Infectious Mononucleosis
510(k) Number K181436
Device Name OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
Applicant
SEKISUI Diagnostics, LLC
6659 Top Gun St.
San Diego,  CA  92121
Applicant Contact Shelly Harris
Correspondent
SEKISUI Diagnostics, LLC
6659 Top Gun St.
San Diego,  CA  92121
Correspondent Contact Shelly Harris
Regulation Number866.5640
Classification Product Code
KTN  
Date Received06/01/2018
Decision Date 06/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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