FDA 510(k)

Xprecia Stride 閃凝系統，Xprecia 系統 PT 控制

K 號：K151964 · 2016-09-30

決定日期2016-09-30

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

Xprecia Stride Coagulation System, Xprecia System PT Controls is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K151964. 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 Xprecia Stride Coagulation System, Xprecia System PT Controls?

Xprecia Stride Coagulation System, Xprecia System PT Controls is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K151964.

When did Xprecia Stride Coagulation System, Xprecia System PT Controls receive FDA 510(k) clearance?

Xprecia Stride Coagulation System, Xprecia System PT Controls received FDA 510(k) clearance on 2016-09-30, under 510(k) number K151964.

Who is the listed applicant for Xprecia Stride Coagulation System, Xprecia System PT Controls?

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

What is the FDA product code for Xprecia Stride Coagulation System, Xprecia System PT Controls?

The FDA product code for Xprecia Stride Coagulation System, Xprecia System PT Controls is GJS.

其他以 Siemens Healthcare Diagnostics 為申請人之記錄

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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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