Terragene® Bionova® BT20 生物指示器
K号: K251122 · 2025-08-04
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申请人Terragene
决定日期2025-08-04
产品代码FRC
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
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相关器械（代码：FRC）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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