NDY

Test, Cystatin C

Product code
NDY
Device name
Test, Cystatin C
Device class
Class 2
21 CFR
21 CFR 862.1225
Medical specialty
Clinical Chemistry
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
0 (direct download)
510(k) clearances (all years, FDA)
22 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-05-16.

NumberDecision dateApplicantDevice nameSummary
K2425852025-05-16SENTINEL CH. SpACystatin CFDA
Official FDA classification page: NDY
Classification and pathway per current FDA publications. Data from openFDA (CC0).