FDA 510(k)

Albumin BCP2

K 號：K203530 · 2022-03-18

決定日期2022-03-18

產品代碼CJW

諮詢委員會CH

決定相當於

器材摘要

Albumin BCP2 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 2022-03-18 under 510(k) number K203530. The device is classified under product code CJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Albumin BCP2?

Albumin BCP2 is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Abbott Ireland Diagnostics Division. The 510(k) number is K203530.

When did Albumin BCP2 receive FDA 510(k) clearance?

Albumin BCP2 received FDA 510(k) clearance on 2022-03-18, under 510(k) number K203530.

Who is the listed applicant for Albumin BCP2?

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 Albumin BCP2?

The FDA product code for Albumin BCP2 is CJW.

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。

K223317鹼性磷酸鹽2 K223324總膽紅素2 K203597膽固醇2 K203771烏拉素氮含量2 K210633Amylase2 K210452肌酐2

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相關器械（代碼：CJW）

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。

K193001Albumin BCPSENTINEL CH. SpA

官方來源

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