FDA 510(k)

Rapicide PA 高级消毒测试条

K号: K152394 · 2016-03-11

决定日期2016-03-11

产品代码JOJ

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

Rapicide PA High-Level Disinfectant Test Strips is the device name listed in this FDA 510(k) record. The listed applicant is Medivators, Inc.. It received FDA 510(k) clearance on 2016-03-11 under 510(k) number K152394. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rapicide PA High-Level Disinfectant Test Strips?

Rapicide PA High-Level Disinfectant Test Strips is a medical device that received FDA 510(k) clearance on 2016-03-11. The listed applicant is Medivators, Inc.. The 510(k) number is K152394.

When did Rapicide PA High-Level Disinfectant Test Strips receive FDA 510(k) clearance?

Rapicide PA High-Level Disinfectant Test Strips received FDA 510(k) clearance on 2016-03-11, under 510(k) number K152394.

Who is the listed applicant for Rapicide PA High-Level Disinfectant Test Strips?

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

What is the FDA product code for Rapicide PA High-Level Disinfectant Test Strips?

The FDA product code for Rapicide PA High-Level Disinfectant Test Strips is JOJ.

列明Medivators, Inc.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：JOJ）

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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