FDA 510(k)

Albumin BCG2

K 號：K203248 · 2021-11-23

決定日期2021-11-23

產品代碼CIX

諮詢委員會CH

決定相當於

器材摘要

Albumin BCG2 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 2021-11-23 under 510(k) number K203248. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Albumin BCG2?

Albumin BCG2 is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Abbott Ireland Diagnostics Division. The 510(k) number is K203248.

When did Albumin BCG2 receive FDA 510(k) clearance?

Albumin BCG2 received FDA 510(k) clearance on 2021-11-23, under 510(k) number K203248.

Who is the listed applicant for Albumin BCG2?

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 BCG2?

The FDA product code for Albumin BCG2 is CIX.

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

查看所有 8 項裝置 →

相關器械（代碼：CIX）

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。

K251157核心代謝Truvian Health K200898Medicon Hellas 藻膠蛋白，Medicon Hellas 钙，Medicon Hellas 肌酸酐，Medicon Hellas 尿素氮，Medicon Hellas 葡萄糖，Medicon Hellas 全總膽紅素，Medicon Hellas 直接膽紅素Medicon Hellas S.A K191316VITROS XT 化學產品 ALB-TP 製品Ortho-Clinical Diagnostics, Inc.K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400Biosystems S.A.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。