FDA 510(k)

3M Attest 快速读数生物指示剂

K号: K160546 · 2016-06-09

决定日期2016-06-09

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

3M Attest Rapid Readout Biological Indicator is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 2016-06-09 under 510(k) number K160546. 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 3M Attest Rapid Readout Biological Indicator?

3M Attest Rapid Readout Biological Indicator is a medical device that received FDA 510(k) clearance on 2016-06-09. The listed applicant is 3M Company. The 510(k) number is K160546.

When did 3M Attest Rapid Readout Biological Indicator receive FDA 510(k) clearance?

3M Attest Rapid Readout Biological Indicator received FDA 510(k) clearance on 2016-06-09, under 510(k) number K160546.

Who is the listed applicant for 3M Attest Rapid Readout Biological Indicator?

The FDA 510(k) record lists 3M Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M Attest Rapid Readout Biological Indicator?

The FDA product code for 3M Attest Rapid Readout Biological Indicator is FRC.

列明3M Company为申报人的其他记录

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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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。

K260766Celerity 5 HP 生物指示剂（LCB052）STERIS Corporation K252680Celerity™ 20 HP 生物指示剂STERIS Corporation K251122Terragene® Bionova® BT20 生物指示器Terragene K251452Celerity 5 HP 生物指示剂（LCB052）；Celerity 5 HP 挑战包（LCB059）；Celerity 20 HP 生物指示剂（LCB044）；Celerity 20 HP 挑战包（LCB045）Steris K250044Celerity 5 HP 生物指示剂（LCB052）；Celerity 5 HP 挑战包（LCB059）；Celerity 20 HP 生物指示剂（LCB044）；Celerity 20 HP 挑战包（LCB045）STERIS Corporation K250061Celerity 孵化箱STERIS Corporation

官方来源

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