FDA 510(k)

HemosIL D-Dimer HS 500

K 號：K172903 · 2017-11-22

決定日期2017-11-22

產品代碼DAP

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

HemosIL D-Dimer HS 500 is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K172903. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HemosIL D-Dimer HS 500?

HemosIL D-Dimer HS 500 is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K172903.

When did HemosIL D-Dimer HS 500 receive FDA 510(k) clearance?

HemosIL D-Dimer HS 500 received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172903.

Who is the listed applicant for HemosIL D-Dimer HS 500?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemosIL D-Dimer HS 500?

The FDA product code for HemosIL D-Dimer HS 500 is DAP.

其他以 Instrumentation Laboratory CO 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。

K221359ACL TOP 970 CL, HemosIL CL 抗心磷脂IgM, HemosIL CL 抗ß2 糖蛋白-I IgM K223187HemosIL 液體抗-Xa K223090GEM預警者化學狀態監測系統 K223402HemosIL 遺傳性血友病因子抗原 K213464HemosIL 液體抗-Xa K213426HemosIL ReadiPlasTin

查看所有 25 項裝置 →

相關器械（代碼：DAP）

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。

K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbH K162227STA® - Liatest® D-DiDiagnostica Stago K160885HemosIL D-Dimer HSInstrumentation Laboratory CO

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。