FDA 510(k)

DiviTum TKa

K-Number: K202852 · 2022-07-29

Decision Date2022-07-29

Product CodeQTE

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

DiviTum TKa is the device name listed in this FDA 510(k) record. The listed applicant is Biovica International AB. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K202852. The device is classified under product code QTE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DiviTum TKa?

DiviTum TKa is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Biovica International AB. The 510(k) number is K202852.

When did DiviTum TKa receive FDA 510(k) clearance?

DiviTum TKa received FDA 510(k) clearance on 2022-07-29, under 510(k) number K202852.

Who is the listed applicant for DiviTum TKa?

The FDA 510(k) record lists Biovica International AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DiviTum TKa?

The FDA product code for DiviTum TKa is QTE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04968964Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity TestingRECRUITING

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.