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FDA 510(k)

PureBMC 超生理濃縮系統 30 mL 系統，PureBMC 超生理濃縮系統 60 mL 系統，PureBMC 超生理濃縮系統 120 mL 系統

K 號：K183205 · 2019-05-30

申請人Emcyte Corporation
決定日期2019-05-30
產品代碼JQC
諮詢委員會CH
決定Unknown

器材摘要

PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System is the device name listed in this FDA 510(k) record. The listed applicant is Emcyte Corporation. It received FDA 510(k) clearance on 2019-05-30 under 510(k) number K183205. The device is classified under product code JQC. It was reviewed by the CH advisory panel. FDA Decision: Unknown.

常見問題

What is the PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System?

PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System is a medical device that received FDA 510(k) clearance on 2019-05-30. The listed applicant is Emcyte Corporation. The 510(k) number is K183205.

When did PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System receive FDA 510(k) clearance?

PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System received FDA 510(k) clearance on 2019-05-30, under 510(k) number K183205.

Who is the listed applicant for PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System?

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

What is the FDA product code for PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System?

The FDA product code for PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System is JQC.

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 Emcyte Corporation 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。

K191564Progenikine 集中系統 25 mL 系統

官方來源

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