DiviTum TKa

Cytokeratin Fragments 21-1 Eia Kit

Biovica International AB

The following data is part of a premarket notification filed by Biovica International Ab with the FDA for Divitum Tka.

Pre-market Notification Details

Device IDK202852
510k NumberK202852
Device Name:DiviTum TKa
ClassificationCytokeratin Fragments 21-1 Eia Kit
Applicant Biovica International AB Dag Hammarskjölds Väg 54B Uppsala,  SE 75237
ContactWing Cheng
CorrespondentJoakim Arwidson
Biovica International AB Dag Hammarskjölds Väg 54B Uppsala,  SE 75237
Product CodeOVK  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-28
Decision Date2022-07-29

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