FDA 510(k)

LOCI 总维生素D总测定，LOCI VITD CAL

K号: K162298 · 2017-03-16

决定日期2017-03-16

产品代码MRG

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决定实质等同

器械摘要

LOCI Total Vitamin D Total Assay, LOCI VITD CAL 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 2017-03-16 under 510(k) number K162298. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LOCI Total Vitamin D Total Assay, LOCI VITD CAL?

LOCI Total Vitamin D Total Assay, LOCI VITD CAL is a medical device that received FDA 510(k) clearance on 2017-03-16. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K162298.

When did LOCI Total Vitamin D Total Assay, LOCI VITD CAL receive FDA 510(k) clearance?

LOCI Total Vitamin D Total Assay, LOCI VITD CAL received FDA 510(k) clearance on 2017-03-16, under 510(k) number K162298.

Who is the listed applicant for LOCI Total Vitamin D Total Assay, LOCI VITD CAL?

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 LOCI Total Vitamin D Total Assay, LOCI VITD CAL?

The FDA product code for LOCI Total Vitamin D Total Assay, LOCI VITD CAL is MRG.

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 2120 K161954Atellica 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)K162538ADVIA 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

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