FDA 510(k)

HardyCHROM ESBL

K 號：K160512 · 2016-11-15

決定日期2016-11-15

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

HardyCHROM ESBL is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K160512. 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 HardyCHROM ESBL?

HardyCHROM ESBL is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Hardy Diagnostics. The 510(k) number is K160512.

When did HardyCHROM ESBL receive FDA 510(k) clearance?

HardyCHROM ESBL received FDA 510(k) clearance on 2016-11-15, under 510(k) number K160512.

Who is the listed applicant for HardyCHROM ESBL?

FDA 510(k) 記錄將 Hardy Diagnostics 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for HardyCHROM ESBL?

The FDA product code for HardyCHROM ESBL is JSO.

其他以 Hardy Diagnostics 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。

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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 Diagnostics K181092CHROMID 卡巴膠 (CARB)Biomerieux S.A.K171061MRSASelect IIBio-Rad K162620瑞美斯普特拉 ESBLRemel, Inc.K162076chromID 靈敏度試驗 MRSAbioMerieux, Inc.K151688chromID 靈敏度試驗 MRSAbioMerieux, Inc.

官方來源

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