FDA 510(k)

LIAISON MeMed BV, LIAISON MeMed BV 控制組

K 號：K213936 · 2022-07-14

決定日期2022-07-14

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

LIAISON MeMed BV, LIAISON MeMed BV Control Set is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2022-07-14 under 510(k) number K213936. 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 LIAISON MeMed BV, LIAISON MeMed BV Control Set?

LIAISON MeMed BV, LIAISON MeMed BV Control Set is a medical device that received FDA 510(k) clearance on 2022-07-14. The listed applicant is DiaSorin, Inc.. The 510(k) number is K213936.

When did LIAISON MeMed BV, LIAISON MeMed BV Control Set receive FDA 510(k) clearance?

LIAISON MeMed BV, LIAISON MeMed BV Control Set received FDA 510(k) clearance on 2022-07-14, under 510(k) number K213936.

Who is the listed applicant for LIAISON MeMed BV, LIAISON MeMed BV Control Set?

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

What is the FDA product code for LIAISON MeMed BV, LIAISON MeMed BV Control Set?

The FDA product code for LIAISON MeMed BV, LIAISON MeMed BV Control Set is QPS.

其他以 DiaSorin, Inc. 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：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.K222332MeMed BVMeMed Diagnostics, Ltd.K210254MeMed BVMeMed Diagnostics, Ltd.

官方來源

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