FDA 510(k)

肌酐2

K 號：K210452 · 2022-03-22

決定日期2022-03-22

產品代碼CGX

諮詢委員會CH

決定相當於

器材摘要

Creatinine2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2022-03-22 under 510(k) number K210452. 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 Creatinine2?

Creatinine2 is a medical device that received FDA 510(k) clearance on 2022-03-22. The listed applicant is Abbott Ireland Diagnostics Division. The 510(k) number is K210452.

When did Creatinine2 receive FDA 510(k) clearance?

Creatinine2 received FDA 510(k) clearance on 2022-03-22, under 510(k) number K210452.

Who is the listed applicant for Creatinine2?

The FDA 510(k) record lists Abbott Ireland Diagnostics Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Creatinine2?

The FDA product code for Creatinine2 is CGX.

其他以 Abbott Ireland Diagnostics Division 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：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 K161494Atellica CH 開創性素_2 (Crea_2), Atellica CH 化學校準器 (CHEM CAL)Siemens Healthcare Diagnostics, Inc.

官方來源

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