FDA 510(k)

Cystatin C

K-Number: K242585 · 2025-05-16

Decision Date2025-05-16

Product CodeNDY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Cystatin C is the device name listed in this FDA 510(k) record. The listed applicant is SENTINEL CH. SpA. It received FDA 510(k) clearance on 2025-05-16 under 510(k) 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. The listed applicant is SENTINEL CH. SpA. The 510(k) number is K242585.

When did Cystatin C receive FDA 510(k) clearance?

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

Who is the listed applicant for Cystatin C?

The FDA 510(k) record lists SENTINEL CH. SpA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cystatin C?

The FDA product code for Cystatin C is NDY.

Other records listing SENTINEL CH. SpA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NDY)

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

Official Source

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