FDA 510(k)

Rapicide PA 高级消毒测试条模型参考号 = ML02-0118

K号: K251048 · 2025-05-02

决定日期2025-05-02

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 Disinfection Test Strip Model Ref # = ML02-0118 is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2025-05-02 under 510(k) number K251048. 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 Disinfection Test Strip Model Ref # = ML02-0118?

Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 is a medical device that received FDA 510(k) clearance on 2025-05-02. The listed applicant is STERIS Corporation. The 510(k) number is K251048.

When did Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 receive FDA 510(k) clearance?

Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 received FDA 510(k) clearance on 2025-05-02, under 510(k) number K251048.

Who is the listed applicant for Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118?

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

What is the FDA product code for Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118?

The FDA product code for Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 is JOJ.

列明STERIS Corporation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。

K2619923M™ Attest™ 蒸汽化学集成器（1243A、1243B、1243RE、1243RES）Solventum US, LLC K260181LF 蒸汽灭菌过程指示胶带Intertape Polymer Group K251991SafeSecure 蒸汽灭菌过程指示器（4012，4013，4014，4016）；SafeSecure 氢氧化过氧化物蒸汽灭菌过程指示器（4211，4212，4213）Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA 测试条Serim Research K243876验证蒸汽集成指示器STERIS Corporation K250172Green Card Bowie-Dick Test (BD115)Steritec Products, Inc. (A Getinge Company)

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