FDA 510(k)

科攀糞便採集、運輸及保存系統

K 號：K220052 · 2022-12-16

決定日期2022-12-16

產品代碼JSM

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

Copan FecalSwab Collection, Transport and Preservation System is the device name listed in this FDA 510(k) record. The listed applicant is Copan Italia Spa. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K220052. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Copan FecalSwab Collection, Transport and Preservation System?

Copan FecalSwab Collection, Transport and Preservation System is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Copan Italia Spa. The 510(k) number is K220052.

When did Copan FecalSwab Collection, Transport and Preservation System receive FDA 510(k) clearance?

Copan FecalSwab Collection, Transport and Preservation System received FDA 510(k) clearance on 2022-12-16, under 510(k) number K220052.

Who is the listed applicant for Copan FecalSwab Collection, Transport and Preservation System?

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

What is the FDA product code for Copan FecalSwab Collection, Transport and Preservation System?

The FDA product code for Copan FecalSwab Collection, Transport and Preservation System is JSM.

其他以 Copan Italia Spa 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。

K232565UriSponge™K232357Copan Universal運輸中間體（UTM-RT）系統 K201849eNAT 分子收集與保存試劑 K180052UriSwab-尿液收集、運輸和保存系統

相關器械（代碼：JSM）

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。

K242976醫用針繩糞便轉移液Cary Blair培養基收集及運輸設備Medical Wire & Equipment Company (Bath), Ltd.K250205Babio® 病毒傳送組合包（非失活型）Jinan Babio Biotechnology Co., Ltd.K242576AllTest 病毒傳播中間體Hangzhou AllTest Biotech Co., Ltd.K232565UriSponge™Copan Italia Spa K220908Ensol EnTM 样本收集及運輸系統Ensol Biosciences, Inc.K240235OmniTrans 輸送系統Shenzhen Dakewe Bio-Engineering Co., Ltd.

官方來源

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