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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K214068
Device Name Quantia IgE
Applicant
Biokit, S.A.
Av. Can Montcau 7
Lliçà D´Amunt,  ES 08186
Applicant Contact Angels Roma
Correspondent
Biokit, S.A.
Av. Can Montcau 7
Lliçà D´Amunt,  ES 08186
Correspondent Contact Angels Roma
Regulation Number866.5510
Classification Product Code
DGC  
Date Received12/27/2021
Decision Date 02/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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