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FDA 510(k)

AllergiEnd ST-9 多皮肤测试应用器，AllergiEnd ST-9 多孔测试板

K号: K172062 · 2018-03-05

申请人Medscience Science Research Group, Inc.
决定日期2018-03-05
产品代码SCL
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

AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray is the device name listed in this FDA 510(k) record. The listed applicant is Medscience Science Research Group, Inc.. It received FDA 510(k) clearance on 2018-03-05 under 510(k) number K172062. The device is classified under product code SCL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray?

AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray is a medical device that received FDA 510(k) clearance on 2018-03-05. The listed applicant is Medscience Science Research Group, Inc.. The 510(k) number is K172062.

When did AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray receive FDA 510(k) clearance?

AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray received FDA 510(k) clearance on 2018-03-05, under 510(k) number K172062.

Who is the listed applicant for AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray?

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

What is the FDA product code for AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray?

The FDA product code for AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray is SCL.

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：SCL）

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

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