Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cystatin C

K-Number: K242585 · 2025-05-16

ApplicantSENTINEL CH. SpA
Decision Date2025-05-16
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Cystatin C is a medical device manufactured by SENTINEL CH. SpA. It received FDA 510(k) clearance on 2025-05-16 under approval number K242585. The device is classified under product code NDY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cystatin C?

Cystatin C is a medical device that received FDA 510(k) clearance on 2025-05-16. It is manufactured by SENTINEL CH. SpA. The 510(k) number is K242585.

When was Cystatin C approved by the FDA?

Cystatin C received FDA 510(k) clearance on 2025-05-16, under approval number K242585.

What company makes Cystatin C?

Cystatin C is manufactured by SENTINEL CH. SpA.

What is the FDA product code for Cystatin C?

The FDA product code for Cystatin C is NDY.

Other Devices by SENTINEL CH. SpA

K173833CRP Vario K193001Albumin BCP K192118CRP Vario K211058Lp(a) Ultra

Related Devices (Code: NDY)

K161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo) K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH K181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑