FDA 510(k)

MeMed BV

K 號：K222332 · 2023-03-23

決定日期2023-03-23

產品代碼QPS

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

MeMed BV is the device name listed in this FDA 510(k) record. The listed applicant is MeMed Diagnostics, Ltd.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K222332. The device is classified under product code QPS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MeMed BV?

MeMed BV is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is MeMed Diagnostics, Ltd.. The 510(k) number is K222332.

When did MeMed BV receive FDA 510(k) clearance?

MeMed BV received FDA 510(k) clearance on 2023-03-23, under 510(k) number K222332.

Who is the listed applicant for MeMed BV?

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

What is the FDA product code for MeMed BV?

The FDA product code for MeMed BV is QPS.

其他以 MeMed Diagnostics, Ltd. 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。

K230944MeMed BV K210254MeMed BV

相關器械（代碼：QPS）

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。

K230944MeMed BVMeMed Diagnostics, Ltd.K213936LIAISON MeMed BV, LIAISON MeMed BV 控制組DiaSorin, Inc.K210254MeMed BVMeMed Diagnostics, Ltd.

官方來源

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