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FDA 510(k)

iSWAB-呼吸道標本收集媒體-提取減少（iSWAB-RC-EL）

K 號：K221802 · 2023-04-03

申請人Mawi Dna Technologies
決定日期2023-04-03
產品代碼QBD
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

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) is the device name listed in this FDA 510(k) record. The listed applicant is Mawi Dna Technologies. It received FDA 510(k) clearance on 2023-04-03 under 510(k) number K221802. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)?

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) is a medical device that received FDA 510(k) clearance on 2023-04-03. The listed applicant is Mawi Dna Technologies. The 510(k) number is K221802.

When did iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) receive FDA 510(k) clearance?

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) received FDA 510(k) clearance on 2023-04-03, under 510(k) number K221802.

Who is the listed applicant for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)?

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

What is the FDA product code for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)?

The FDA product code for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) is QBD.

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。

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相關器械（代碼：QBD）

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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官方來源

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