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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kappa, Antigen, Antiserum, Control
510(k) Number K210623
Device Name FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
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 Number866.5550
Classification Product Code
DFH  
Subsequent Product Code
DEH  
Date Received03/02/2021
Decision Date 11/18/2022
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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