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FDA 510(k)

Medblue皮肤点刺试验应用器（AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172）

K号: K250983 · 2026-01-30

申请人Asistan Medikal
决定日期2026-01-30
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

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) is the device name listed in this FDA 510(k) record. The listed applicant is Asistan Medikal. It received FDA 510(k) clearance on 2026-01-30 under 510(k) number K250983. 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 Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)?

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Asistan Medikal. The 510(k) number is K250983.

When did Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) receive FDA 510(k) clearance?

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) received FDA 510(k) clearance on 2026-01-30, under 510(k) number K250983.

Who is the listed applicant for Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)?

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

What is the FDA product code for Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)?

The FDA product code for Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) 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。

K222385分叉针Anhui Tiankang Medical Technology Co., Ltd.K182582Oryum 和 Ovem 表皮真皮刺试验应用器Allergy & Applicator Depot, LLCK172062AllergiEnd ST-9 多皮肤测试应用器，AllergiEnd ST-9 多孔测试板Medscience Science Research Group, Inc.K162917Allerhope 过敏皮肤测试仪Procare Industrial Co., Limited

官方来源

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