FDA 510(k)

Coag-Sense Prothrombin (PT) / INR 監測系統用於病人自我測試

K 號：K212779 · 2022-10-05

決定日期2022-10-05

產品代碼GJS

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing is the device name listed in this FDA 510(k) record. The listed applicant is Coagusense, Inc.. It received FDA 510(k) clearance on 2022-10-05 under 510(k) number K212779. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing?

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing is a medical device that received FDA 510(k) clearance on 2022-10-05. The listed applicant is Coagusense, Inc.. The 510(k) number is K212779.

When did Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing receive FDA 510(k) clearance?

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing received FDA 510(k) clearance on 2022-10-05, under 510(k) number K212779.

Who is the listed applicant for Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing?

The FDA 510(k) record lists Coagusense, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing?

The FDA product code for Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing is GJS.

其他以 Coagusense, Inc. 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。

K183255Coag-Sense 頸內凝血時間（PT）/國際正常化比值（INR）監測裝置

相關器械（代碼：GJS）

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。

K253188CoaguChek XS Plus 系統Roche Diagnostics K251564微INR系統Iline Microsystems, S.L.K243543微INR系統Iline Microsystems, S.L.K230802Xprecia Prime 凝血系統Universal Biosensors Pty, Ltd.K220282i-STAT PTplus 車籠，配用 i-STAT 1 系統Abbott Laboratories K231711微INR系統Iline Microsystems, S.L.

官方來源

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