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FDA 510(k)

DiaSys Procalcitonin FS；DiaSys TruCal Procalcitonin 定標準組合；DiaSys TruLab Procalcitonin 兩級控制標準

K 號：K242294 · 2025-05-09

申請人Diasys Diagnostic Systems GmbH
決定日期2025-05-09
產品代碼PTF
諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)
決定相當於

器材摘要

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls is the device name listed in this FDA 510(k) record. The listed applicant is Diasys Diagnostic Systems GmbH. It received FDA 510(k) clearance on 2025-05-09 under 510(k) number K242294. The device is classified under product code PTF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls?

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Diasys Diagnostic Systems GmbH. The 510(k) number is K242294.

When did DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls receive FDA 510(k) clearance?

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls received FDA 510(k) clearance on 2025-05-09, under 510(k) number K242294.

Who is the listed applicant for DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls?

The FDA 510(k) record lists Diasys Diagnostic Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls?

The FDA product code for DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls is PTF.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：PTF）

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。

K222996AccessPCTBeckman Coulter, Inc.K192271AccessPCT, AccessPCT校准器Beckman Coulter, Inc.K162297迪亞茲美普羅鈣調素（PCT）測試，迪亞茲美普羅鈣調素（PCT）校准組，迪亞茲美普羅鈣調素（PCT）控制組Diazyme Laboratories

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