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FDA 510(k)

AFIAS TSH-SP，AFIAS TSH-VB，AFIAS-6/SP 分析仪，AFIAS-6/VB 分析仪

K号: K170232 · 2017-10-13

申请人Boditech Med, Inc.
决定日期2017-10-13
产品代码JLW
咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Boditech Med, Inc.. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K170232. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer?

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Boditech Med, Inc.. The 510(k) number is K170232.

When did AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer receive FDA 510(k) clearance?

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer received FDA 510(k) clearance on 2017-10-13, under 510(k) number K170232.

Who is the listed applicant for AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer?

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

What is the FDA product code for AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer?

The FDA product code for AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer is JLW.

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：JLW）

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。

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI促甲状腺激素灵活试剂盒（TSHL）；Dimension LOCI游离甲状腺素灵活试剂盒（FT4L）Siemens Healthcare DiagnosticsK234091Maverick诊断系统TC1000；Maverick测试面板A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI 分析仪, Atellica® IM 促甲状腺激素 3-Ultra (TSH3-UL), Atellica® CH 白蛋白BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) 测定，DxI 9000 Access 免疫测定分析仪Beckman Coulter, Inc.

官方来源

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