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FDA 510(k)

Curian® 肽毒素

K 號:K222829 · 2023-04-17

決定日期2023-04-17
產品代碼GMZ
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

Curian® Shiga Toxin is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2023-04-17 under 510(k) number K222829. The device is classified under product code GMZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Curian® Shiga Toxin?

Curian® Shiga Toxin is a medical device that received FDA 510(k) clearance on 2023-04-17. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K222829.

When did Curian® Shiga Toxin receive FDA 510(k) clearance?

Curian® Shiga Toxin received FDA 510(k) clearance on 2023-04-17, under 510(k) number K222829.

Who is the listed applicant for Curian® Shiga Toxin?

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

What is the FDA product code for Curian® Shiga Toxin?

The FDA product code for Curian® Shiga Toxin is GMZ.

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其他以 Meridian Bioscience, Inc. 為申請人之記錄

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