FDA 510(k)

自动免疫分析系统HISCL -800，HISCL TSH检测套件，HISCL TSH校准器，HISCL免疫多控制

K号: K160541 · 2016-10-21

决定日期2016-10-21

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

Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex America, Inc.. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K160541. 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 Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control?

Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is Sysmex America, Inc.. The 510(k) number is K160541.

When did Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control receive FDA 510(k) clearance?

Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control received FDA 510(k) clearance on 2016-10-21, under 510(k) number K160541.

Who is the listed applicant for Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control?

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

What is the FDA product code for Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control?

The FDA product code for Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control is JLW.

列明Sysmex America, Inc.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。

K253212XR系列（XR-10，XR-20）自动血液分析仪 K250943Sysmex XR-Series (XR-10) 自动血液分析仪 K251371Sysmex XR-Series (XR-20) 自动血液分析仪 K250965自动血凝分析仪CN系列（CN-6000）K230887Sysmex XQ-Series (XQ-320) 自动血液分析仪 K210346Sysmex XW-100 自动血液分析仪

查看所有 12 个设备 →

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 Diagnostics K234091Maverick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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