FDA 510(k)

Albumin BCP

K 號：K193001 · 2019-12-19

決定日期2019-12-19

產品代碼CJW

諮詢委員會CH

決定相當於

器材摘要

Albumin BCP is the device name listed in this FDA 510(k) record. The listed applicant is SENTINEL CH. SpA. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K193001. 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 BCP?

Albumin BCP is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is SENTINEL CH. SpA. The 510(k) number is K193001.

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

Albumin BCP received FDA 510(k) clearance on 2019-12-19, under 510(k) number K193001.

Who is the listed applicant for Albumin BCP?

The FDA 510(k) record lists SENTINEL CH. SpA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Albumin BCP?

The FDA product code for Albumin BCP is CJW.

其他以 SENTINEL CH. SpA 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。

K242585膽素C K211058Lp(a) 超級 K192118CRP Vario K173833CRP Vario

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。

K203530Albumin BCP2Abbott Ireland Diagnostics Division

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。