FDA 510(k)

HemosIL AcuStar HIT-IgG(PF4-H)，HemosIL AcuStar HIT控制

K 號：K170854 · 2017-09-08

決定日期2017-09-08

產品代碼LCO

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 AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls 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 2017-09-08 under 510(k) number K170854. The device is classified under product code LCO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls?

HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K170854.

When did HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls receive FDA 510(k) clearance?

HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls received FDA 510(k) clearance on 2017-09-08, under 510(k) number K170854.

Who is the listed applicant for HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls?

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 AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls?

The FDA product code for HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls is LCO.

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：LCO）

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。

K243374HemosIL CL HIT-IgG(PF4-H)Instrumentation Laboratory (IL) Co.K201570PF4增強試驗Immucor Gti Diagnostics, Inc.K201311PF4 IgG 測試Immucor Gti Diagnostics, Inc.K153137HemosIL HIT-Ab(PF4-H)，HemosIL HIT-Ab(PF4-H) 控制劑Instrumentation Laboratory CO

官方來源

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