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FDA 510(k)

Terragene® Bionova® BT20 生物指示劑

K 號：K251122 · 2025-08-04

申請人Terragene
決定日期2025-08-04
產品代碼FRC
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

Terragene® Bionova® BT20 Biological Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Terragene. It received FDA 510(k) clearance on 2025-08-04 under 510(k) number K251122. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Terragene® Bionova® BT20 Biological Indicator?

Terragene® Bionova® BT20 Biological Indicator is a medical device that received FDA 510(k) clearance on 2025-08-04. The listed applicant is Terragene. The 510(k) number is K251122.

When did Terragene® Bionova® BT20 Biological Indicator receive FDA 510(k) clearance?

Terragene® Bionova® BT20 Biological Indicator received FDA 510(k) clearance on 2025-08-04, under 510(k) number K251122.

Who is the listed applicant for Terragene® Bionova® BT20 Biological Indicator?

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

What is the FDA product code for Terragene® Bionova® BT20 Biological Indicator?

The FDA product code for Terragene® Bionova® BT20 Biological Indicator is FRC.

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