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FDA 510(k)

APAS Independence 內建 IC 遊離基 MRSA BD 分析模組；APAS Independence 內建 IC 遊離基 MRSA TFS/S 分析模組

K 號：K200839 · 2021-10-28

申請人Clever Culture Systems
決定日期2021-10-28
產品代碼QQY
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

APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module is the device name listed in this FDA 510(k) record. The listed applicant is Clever Culture Systems. It received FDA 510(k) clearance on 2021-10-28 under 510(k) number K200839. The device is classified under product code QQY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module?

APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module is a medical device that received FDA 510(k) clearance on 2021-10-28. The listed applicant is Clever Culture Systems. The 510(k) number is K200839.

When did APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module receive FDA 510(k) clearance?

APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module received FDA 510(k) clearance on 2021-10-28, under 510(k) number K200839.

Who is the listed applicant for APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module?

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

What is the FDA product code for APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module?

The FDA product code for APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module is QQY.

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：QQY）

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。

K213280BD Kiestra 耐甲氧西林葡萄球菌 (MRSA) 應用，BD Kiestra MRSA AppBd Kiestra B.V.

官方來源

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