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FDA 510(k)

Accelerate Pheno System, Accelerate PhenoTest BC Kit

K 號：K192665 · 2020-09-15

申請人Accelerate Diagnostics, Inc.
決定日期2020-09-15
產品代碼PRH
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

Accelerate Pheno System, Accelerate PhenoTest BC Kit is the device name listed in this FDA 510(k) record. The listed applicant is Accelerate Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-09-15 under 510(k) number K192665. The device is classified under product code PRH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Accelerate Pheno System, Accelerate PhenoTest BC Kit?

Accelerate Pheno System, Accelerate PhenoTest BC Kit is a medical device that received FDA 510(k) clearance on 2020-09-15. The listed applicant is Accelerate Diagnostics, Inc.. The 510(k) number is K192665.

When did Accelerate Pheno System, Accelerate PhenoTest BC Kit receive FDA 510(k) clearance?

Accelerate Pheno System, Accelerate PhenoTest BC Kit received FDA 510(k) clearance on 2020-09-15, under 510(k) number K192665.

Who is the listed applicant for Accelerate Pheno System, Accelerate PhenoTest BC Kit?

The FDA 510(k) record lists Accelerate Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accelerate Pheno System, Accelerate PhenoTest BC Kit?

The FDA product code for Accelerate Pheno System, Accelerate PhenoTest BC Kit is PRH.

相關臨床試驗

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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 Accelerate Diagnostics, Inc. 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。

K240854Accelerate Arc System

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