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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoelectrophoretic, Immunoglobulins, (G, A, M)
510(k) Number K192095
Device Name CAPI 3 Immunotyping, Capillarys 3 Tera
Applicant
Sebia
1705 Corporate Dr., Suite 400
Norcross,  GA  30093
Applicant Contact Karen Anderson
Correspondent
Sebia
1705 Corporate Dr., Suite 400
Norcross,  GA  30093
Correspondent Contact Karen Anderson
Regulation Number866.5510
Classification Product Code
CFF  
Subsequent Product Codes
CEF   DEH   DFH  
Date Received08/05/2019
Decision Date 11/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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