INNOVANCE 抗凝血劑
K 號：K242952 · 2025-03-28
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決定日期2025-03-28
產品代碼JBQ
諮詢委員會HE
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決定相當於
器材摘要
INNOVANCE Antithrombin is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostic Products GmbH. It received FDA 510(k) clearance on 2025-03-28 under 510(k) number K242952. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the INNOVANCE Antithrombin?
INNOVANCE Antithrombin is a medical device that received FDA 510(k) clearance on 2025-03-28. The listed applicant is Siemens Healthcare Diagnostic Products GmbH. The 510(k) number is K242952.
When did INNOVANCE Antithrombin receive FDA 510(k) clearance?
INNOVANCE Antithrombin received FDA 510(k) clearance on 2025-03-28, under 510(k) number K242952.
Who is the listed applicant for INNOVANCE Antithrombin?
FDA 510(k) 記錄中將西门子醫療診斷產品有限公司列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for INNOVANCE Antithrombin?
The FDA product code for INNOVANCE Antithrombin is JBQ.
相關臨床試驗
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其他以 Siemens Healthcare Diagnostic Products GmbH 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。
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。
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