FDA 510(k)

Atellica CH 酶促性肌酸酐_3 (ECre3)

K 號：K212223 · 2021-11-24

決定日期2021-11-24

產品代碼JFY

諮詢委員會CH

決定相當於

器材摘要

Atellica CH Enzymatic Creatinine_3 (ECre3) 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 2021-11-24 under 510(k) number K212223. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Atellica CH Enzymatic Creatinine_3 (ECre3)?

Atellica CH Enzymatic Creatinine_3 (ECre3) is a medical device that received FDA 510(k) clearance on 2021-11-24. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K212223.

When did Atellica CH Enzymatic Creatinine_3 (ECre3) receive FDA 510(k) clearance?

Atellica CH Enzymatic Creatinine_3 (ECre3) received FDA 510(k) clearance on 2021-11-24, under 510(k) number K212223.

Who is the listed applicant for Atellica CH Enzymatic Creatinine_3 (ECre3)?

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 Atellica CH Enzymatic Creatinine_3 (ECre3)?

The FDA product code for Atellica CH Enzymatic Creatinine_3 (ECre3) is JFY.

其他以 Siemens Healthcare Diagnostics, Inc. 為申請人之記錄

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相關器械（代碼：JFY）

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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