DeviceClearance

Product code LTK— Immunology

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Classification name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Device class
Class 2
Regulation
21 CFR 866.6010
Advisory panel
Immunology
Total cleared
26
First cleared
Most recent

Market context for product code LTK

FDA has cleared 26 devices under product code LTK between 1997 and 2024, filed by 17 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code LTK

Recent clearances under product code LTK

Data sourced from openFDA. This site is unofficial and independent of the FDA.