FDA 510(k)

PF4增強試驗

K 號：K201570 · 2020-09-11

決定日期2020-09-11

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

PF4 Enhanced assay is the device name listed in this FDA 510(k) record. The listed applicant is Immucor Gti Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K201570. 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 PF4 Enhanced assay?

PF4 Enhanced assay is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Immucor Gti Diagnostics, Inc.. The 510(k) number is K201570.

When did PF4 Enhanced assay receive FDA 510(k) clearance?

PF4 Enhanced assay received FDA 510(k) clearance on 2020-09-11, under 510(k) number K201570.

Who is the listed applicant for PF4 Enhanced assay?

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

What is the FDA product code for PF4 Enhanced assay?

The FDA product code for PF4 Enhanced assay is LCO.

其他以 Immucor Gti Diagnostics, 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。

K201311PF4 IgG 測試

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.K201311PF4 IgG 測試Immucor Gti Diagnostics, Inc.K170854HemosIL AcuStar HIT-IgG(PF4-H)，HemosIL AcuStar HIT控制Instrumentation Laboratory CO K153137HemosIL HIT-Ab(PF4-H)，HemosIL HIT-Ab(PF4-H) 控制劑Instrumentation Laboratory CO

官方來源

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