DeviceClearance

Product code NDY— Clinical Chemistry

GENTIAN CYSTATIN C IMMUNOASSAY

Classification name
Test, Cystatin C
Device class
Class 2
Regulation
21 CFR 862.1225
Advisory panel
Clinical Chemistry
Total cleared
22
First cleared
Most recent

Market context for product code NDY

FDA has cleared 22 devices under product code NDY between 2001 and 2025, 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 NDY

Recent clearances under product code NDY

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