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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
510(k) Number K123182
Device Name OSOM INFLUENZA A&B TEST MODEL 190
Applicant
SEKISUI Diagnostics, LLC
6659 Top Gun St.
San Diego,  CA  92121
Applicant Contact MARK STAVRO
Correspondent
SEKISUI Diagnostics, LLC
6659 Top Gun St.
San Diego,  CA  92121
Correspondent Contact MARK STAVRO
Regulation Number866.3330
Classification Product Code
GNX  
Date Received10/10/2012
Decision Date 11/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
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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