FDA 510(k)

ADVIA 化學胱氨酸 C_2 檢測 (CYSC_2)

K 號：K181082 · 2018-05-25

決定日期2018-05-25

產品代碼NDY

諮詢委員會CH

決定相當於

器材摘要

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K181082. 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 ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)?

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K181082.

When did ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) receive FDA 510(k) clearance?

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) received FDA 510(k) clearance on 2018-05-25, under 510(k) number K181082.

Who is the listed applicant for ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)?

FDA 510(k) 記錄將西门子醫療診斷公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)?

The FDA product code for ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) is NDY.

其他以 Siemens Healthcare Diagnostics, Inc. 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。

K242585膽素CSENTINEL CH. SpA K171072N 胶乳胱氨酸C；N 蛋白質標準 UYSiemens Healthcare Diagnostics Products GmbH K161817Tina-quant 胱素 C Gen.2Roche Diagnostics Operations (Rdo)

官方來源

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