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FDA 510(k)

Atellica Solution, Atellica A-LYTE 集成多传感器 Na+/K+/CI-, Atellica CH 白蛋白BCP试剂 (Alb_p), Atellica IM 促甲状腺激素 TSH, Atellica CH 万古霉素 (Vanc)

K号: K161954 · 2017-03-09

申请人Siemens Healthcare Diagnostics
决定日期2017-03-09
产品代码JGS
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

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2017-03-09 under 510(k) number K161954. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)?

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) is a medical device that received FDA 510(k) clearance on 2017-03-09. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K161954.

When did Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) receive FDA 510(k) clearance?

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) received FDA 510(k) clearance on 2017-03-09, under 510(k) number K161954.

Who is the listed applicant for Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)?

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

What is the FDA product code for Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)?

The FDA product code for Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) is JGS.

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

列明Siemens Healthcare Diagnostics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。

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）K162977ADVIA 2120i, ADVIA 2120K162298LOCI 总维生素D总测定，LOCI VITD CALK162538ADVIA Centaur 胰岛素（IRI）主曲线材料（MCM），ADVIA Centaur（IRI）校准器K151964Xprecia Stride 凝血系统，Xprecia 系统 PT 控制

相关器械（代码：JGS）

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。

K252475ABL90 FLEX PLUS 系统Radiometer Medicals ApsK230275i-STAT CG8+ 芯片，适用于 i-STAT 1 系统Abbott Point of Care, Inc.K222438A-LYTE® 集成多传感器（IMT Na K Cl）Siemens Healthcare Diagnostics, Inc.K220977ISE 试剂，葡萄糖，CRP 橡胶，DxC 500 AU 临床化学分析仪Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP 系统跟踪Abbott LaboratoriesK200403Stat Profile Prime Plus分析系统Nova Biomedical Corporation

官方来源

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