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FDA 510(k)

瑞美斯普特拉 ESBL

K 號：K162620 · 2017-05-01

申請人Remel, Inc.
決定日期2017-05-01
產品代碼JSO
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

Remel Spectra ESBL is the device name listed in this FDA 510(k) record. The listed applicant is Remel, Inc.. It received FDA 510(k) clearance on 2017-05-01 under 510(k) number K162620. The device is classified under product code JSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Remel Spectra ESBL?

Remel Spectra ESBL is a medical device that received FDA 510(k) clearance on 2017-05-01. The listed applicant is Remel, Inc.. The 510(k) number is K162620.

When did Remel Spectra ESBL receive FDA 510(k) clearance?

Remel Spectra ESBL received FDA 510(k) clearance on 2017-05-01, under 510(k) number K162620.

Who is the listed applicant for Remel Spectra ESBL?

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

What is the FDA product code for Remel Spectra ESBL?

The FDA product code for Remel Spectra ESBL is JSO.

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：JSO）

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。

K190553HardyCHROM 医療設備規範文本 HardyCHROM 医療設備 FDA 510(k) PMA NCT PMID 識別碼 網址Hardy DiagnosticsK181092CHROMID 卡巴膠 (CARB)Biomerieux S.A.K171061MRSASelect IIBio-RadK160512HardyCHROM ESBLHardy DiagnosticsK162076chromID 靈敏度試驗 MRSAbioMerieux, Inc.K151688chromID 靈敏度試驗 MRSAbioMerieux, Inc.

官方來源

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