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FDA 510(k)

X100 配合全場周邊血液涂片（PBS）應用

K 號：K201301 · 2020-10-02

申請人Scopio Labs , Ltd.
決定日期2020-10-02
產品代碼JOY
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

X100 with Full Field Peripheral Blood Smear (PBS) Application is the device name listed in this FDA 510(k) record. The listed applicant is Scopio Labs , Ltd.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K201301. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the X100 with Full Field Peripheral Blood Smear (PBS) Application?

X100 with Full Field Peripheral Blood Smear (PBS) Application is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Scopio Labs , Ltd.. The 510(k) number is K201301.

When did X100 with Full Field Peripheral Blood Smear (PBS) Application receive FDA 510(k) clearance?

X100 with Full Field Peripheral Blood Smear (PBS) Application received FDA 510(k) clearance on 2020-10-02, under 510(k) number K201301.

Who is the listed applicant for X100 with Full Field Peripheral Blood Smear (PBS) Application?

The FDA 510(k) record lists Scopio Labs , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X100 with Full Field Peripheral Blood Smear (PBS) Application?

The FDA product code for X100 with Full Field Peripheral Blood Smear (PBS) Application is JOY.

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

其他以 Scopio Labs , Ltd. 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。

K243144X100/X100HT 內建全場域周邊血液涂片（PBS）應用K220013X100HT 配備滑動加載器，全場周邊血液涂片（PBS）應用

相關器械（代碼：JOY）

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。

K243144X100/X100HT 內建全場域周邊血液涂片（PBS）應用Scopio Labs , Ltd.K221309AI100 with ShonitSigtuple Technologies Pvt. , Ltd.K220013X100HT 配備滑動加載器，全場周邊血液涂片（PBS）應用Scopio Labs , Ltd.K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision ABK182062Sysmex UD-10，全自動尿沉渣數位影像設備Sysmex America, Inc.K171315先進紅血球應用CellaVision AB

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