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

Thymidine Kinase Activity

21 CFR 866.6010 / Immunology
FDA source (opens on fda.gov)

QTE is the FDA product code for Thymidine Kinase Activity, a class II device type, regulated under 21 CFR 866.6010. FDA's definition for this code reads: "In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QTE
Device name
Thymidine Kinase Activity
FDA definition
In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients.
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QTE

By decision year
1 clearance under product code QTE with a decision year between 2022 and 2022, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QTE by decision year
YearClearances
20221

Applicants with the most clearances

Product code QTE
Applicants holding the most 510(k) clearances under product code QTE
ApplicantClearances
Biovica International AB1

Companies listing this code with FDA

Companies whose registered establishments list this code