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FDA 510(k)

N 胶乳胱氨酸C；N 蛋白質標準 UY

K 號：K171072 · 2017-05-12

申請人Siemens Healthcare Diagnostics Products GmbH
決定日期2017-05-12
產品代碼NDY
諮詢委員會CH
決定相當於

器材摘要

N Latex Cystatin C; N Protein Standard UY is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2017-05-12 under 510(k) number K171072. 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 N Latex Cystatin C; N Protein Standard UY?

N Latex Cystatin C; N Protein Standard UY is a medical device that received FDA 510(k) clearance on 2017-05-12. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K171072.

When did N Latex Cystatin C; N Protein Standard UY receive FDA 510(k) clearance?

N Latex Cystatin C; N Protein Standard UY received FDA 510(k) clearance on 2017-05-12, under 510(k) number K171072.

Who is the listed applicant for N Latex Cystatin C; N Protein Standard UY?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N Latex Cystatin C; N Protein Standard UY?

The FDA product code for N Latex Cystatin C; N Protein Standard UY is NDY.

相關臨床試驗

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其他以 Siemens Healthcare Diagnostics Products GmbH 為申請人之記錄

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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. SpAK181082ADVIA 化學胱氨酸 C_2 檢測 (CYSC_2)Siemens Healthcare Diagnostics, Inc.K161817Tina-quant 胱素 C Gen.2Roche Diagnostics Operations (Rdo)

官方來源

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