FDA 510(k)

Atellica CH 開創性素_2 (Crea_2), Atellica CH 化學校準器 (CHEM CAL)

K 號：K161494 · 2016-11-15

決定日期2016-11-15

產品代碼CGX

諮詢委員會CH

決定相當於

器材摘要

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) 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 2016-11-15 under 510(k) number K161494. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)?

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K161494.

When did Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) receive FDA 510(k) clearance?

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) received FDA 510(k) clearance on 2016-11-15, under 510(k) number K161494.

Who is the listed applicant for Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)?

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 Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)?

The FDA product code for Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) is CGX.

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

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相關器械（代碼：CGX）

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。

K252206諾瓦阿萊gro UACR試劑，諾瓦阿萊gro分析儀Nova Biomedical Corporation K251058真兒童腎臟健康檢測組合；真分析器Truvian Health K242685Atellica® CH 创酸_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813諾瓦阿萊gro UACR試劑，諾瓦阿萊gro分析儀Nova Biomedical Corporation K210452肌酐2Abbott Ireland Diagnostics Division

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