FDA 510(k)

HemosIL D-Dimer HS

K 號：K160885 · 2016-10-27

決定日期2016-10-27

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 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 2016-10-27 under 510(k) number K160885. 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?

HemosIL D-Dimer HS is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K160885.

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

HemosIL D-Dimer HS received FDA 510(k) clearance on 2016-10-27, under 510(k) number K160885.

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

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?

The FDA product code for HemosIL D-Dimer HS 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

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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 K172903HemosIL D-Dimer HS 500Instrumentation Laboratory CO K162227STA® - Liatest® D-DiDiagnostica Stago

官方來源

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