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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thymidine Kinase Activity
510(k) Number K202852
Device Name DiviTum TKa
Applicant
Biovica International AB
Dag Hammarskjölds Väg 54b
Uppsala,  SE 75237
Applicant Contact Joakim Arwidson
Correspondent
Biovica International AB
Dag Hammarskjölds Väg 54b
Uppsala,  SE 75237
Correspondent Contact Joakim Arwidson
Regulation Number866.6010
Classification Product Code
QTE  
Date Received09/28/2020
Decision Date 07/29/2022
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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