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FDA 510(k)

Kem医疗无铅化学指示剂，用于蒸汽灭菌

K号: K241836 · 2024-09-30

申请人Kem Medical Products Corporation
决定日期2024-09-30
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

Kem Medical Lead-free Chemical Indicators for Steam Sterilization is the device name listed in this FDA 510(k) record. The listed applicant is Kem Medical Products Corporation. It received FDA 510(k) clearance on 2024-09-30 under 510(k) number K241836. 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 Kem Medical Lead-free Chemical Indicators for Steam Sterilization?

Kem Medical Lead-free Chemical Indicators for Steam Sterilization is a medical device that received FDA 510(k) clearance on 2024-09-30. The listed applicant is Kem Medical Products Corporation. The 510(k) number is K241836.

When did Kem Medical Lead-free Chemical Indicators for Steam Sterilization receive FDA 510(k) clearance?

Kem Medical Lead-free Chemical Indicators for Steam Sterilization received FDA 510(k) clearance on 2024-09-30, under 510(k) number K241836.

Who is the listed applicant for Kem Medical Lead-free Chemical Indicators for Steam Sterilization?

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

What is the FDA product code for Kem Medical Lead-free Chemical Indicators for Steam Sterilization?

The FDA product code for Kem Medical Lead-free Chemical Indicators for Steam Sterilization is JOJ.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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, LLCK260181LF 蒸汽灭菌过程指示胶带Intertape Polymer GroupK251991SafeSecure 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 ResearchK251048Rapicide PA 高级消毒测试条 模型参考号 = ML02-0118STERIS CorporationK243876验证蒸汽集成指示器STERIS Corporation

官方来源

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