FDA 510(k)

HemosIL CL HIT-IgG(PF4-H)

K 號：K243374 · 2025-01-28

決定日期2025-01-28

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 CL HIT-IgG(PF4-H) is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory (IL) Co.. It received FDA 510(k) clearance on 2025-01-28 under 510(k) number K243374. 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 CL HIT-IgG(PF4-H)?

HemosIL CL HIT-IgG(PF4-H) is a medical device that received FDA 510(k) clearance on 2025-01-28. The listed applicant is Instrumentation Laboratory (IL) Co.. The 510(k) number is K243374.

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

HemosIL CL HIT-IgG(PF4-H) received FDA 510(k) clearance on 2025-01-28, under 510(k) number K243374.

Who is the listed applicant for HemosIL CL HIT-IgG(PF4-H)?

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

What is the FDA product code for HemosIL CL HIT-IgG(PF4-H)?

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

其他以 Instrumentation Laboratory (IL) 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。

K260551HemosIL 因子V Leiden (抗凝血酶蛋白C抵抗V)K253957HemosIL 硅膠凝血時間 K251968HemosIL 纤维蛋白原-C；HemosIL 纤维蛋白原-C XL K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)

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。

K201570PF4增強試驗Immucor Gti Diagnostics, Inc.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

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。