FDA 510(k)

膽素C

K 號：K242585 · 2025-05-16

決定日期2025-05-16

產品代碼NDY

諮詢委員會CH

決定相當於

器材摘要

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.

常見問題

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.

其他以 SENTINEL CH. SpA 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：NDY）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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