FDA 510(k)

ACL TOP 970 CL, HemosIL CL 抗心磷脂IgM, HemosIL CL 抗ß2 糖蛋白-I IgM

K 號：K221359 · 2023-09-29

決定日期2023-09-29

產品代碼JPA

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

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM 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 2023-09-29 under 510(k) number K221359. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM?

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K221359.

When did ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM receive FDA 510(k) clearance?

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM received FDA 510(k) clearance on 2023-09-29, under 510(k) number K221359.

Who is the listed applicant for ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM?

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 ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM?

The FDA product code for ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM is JPA.

其他以 Instrumentation Laboratory CO 為申請人之記錄

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相關器械（代碼：JPA）

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。

K253658STA衛星Max®Diagnostica Stago, Inc.K250965自動血液凝固分析儀CN系列（CN-6000）Sysmex America, Inc.K251024TEG 6s 止血系統經鹽酸處理：K, KH, RT, FF 測試卡匣Haemonetics K243858TEG 6s 止血系統經鹽酸處理：K, KH, RT, FF 測試卡匣Haemonetics Corporation K232018Citrated: K, KH, RTH, FFHHaemonetics Corporation K233790ACL TOP 970 CLInstrumentation Laboratory

官方來源

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