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FDA 510(k)

IMMULITE 2000 第三代 TSH，IMMULITE 2000 游离 T4

K号: K160647 · 2016-05-31

申请人Siemens Healthcare Diagnostics, Inc.
决定日期2016-05-31
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

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-05-31 under 510(k) number K160647. 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 IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4?

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 is a medical device that received FDA 510(k) clearance on 2016-05-31. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K160647.

When did IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 receive FDA 510(k) clearance?

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 received FDA 510(k) clearance on 2016-05-31, under 510(k) number K160647.

Who is the listed applicant for IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4?

FDA 510(k)记录中列出西门子医疗诊断公司（Siemens Healthcare Diagnostics, Inc.）为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4?

The FDA product code for IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 is JLW.

相关临床试验

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列明Siemens Healthcare Diagnostics, 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。

K253528Atellica IM CA 19-9 IIK261364Atellica CH 对乙酰氨基酚 2 (ACTM)K251998Atellica CH 碘化物总胆红素 (D_TBil)K251543Atellica® IM TSH3-Ultra II (TSH3ULII)K251630Atellica IM 总PSA II (tPSAII)K250816ADVIA Centaur 抗甲状腺球蛋白II (aTgII)

查看所有 64 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 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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