510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202852Substantially Equivalent

DiviTum TKa

Biovica International AB, Uppsala, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202852 is the FDA 510(k) clearance record for DiviTum TKa, a class II device, cleared for Biovica International AB on under FDA product code QTE (Thymidine Kinase Activity). FDA's definition for product code QTE reads: "In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients". FDA records list one 510(k) clearance for Biovica International AB. As of , FDA records show no recalls naming K202852.

Clearance record

Decision date
Received
(669 days to decision)
Product code
QTE Thymidine Kinase Activity
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Biovica International AB Dag Hammarskjölds Väg 54b, Uppsala, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QTE

Trailing 12 months

FDA records hold no clearances under product code QTE in the trailing twelve months.

FDA records show no clearances under product code QTE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QTE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260