FDA 510(k)

宙斯ELISA伯氏螺旋体VlsE1/pepC10 IgG/IgM检测系统；宙斯ELISA伯氏疏螺旋体IgM检测系统

K号: K191240 · 2019-07-29

决定日期2019-07-29

产品代码LSR

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决定实质等同

器械摘要

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 2019-07-29 under 510(k) number K191240. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System?

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System is a medical device that received FDA 510(k) clearance on 2019-07-29. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K191240.

When did ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System receive FDA 510(k) clearance?

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System received FDA 510(k) clearance on 2019-07-29, under 510(k) number K191240.

Who is the listed applicant for ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System?

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

What is the FDA product code for ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System?

The FDA product code for ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System is LSR.

列明Zeus Scientific, 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。

K201956宙斯 IFA ANA HEp-2 测试系统，宙斯 dIFine K191398宙斯ELISA伯氏螺旋体VlsE1/pepC10 IgG/IgM检测系统；宙斯ELISA伯氏疏螺旋体IgG检测系统 K190907宙斯ELISA伯氏疏螺旋体VlsE1/pepC10 IgG/IgM检测系统；宙斯ELISA伯氏疏螺旋体IgG/IgM检测系统

相关器械（代码：LSR）

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。

K254295Sofia Lyme FIA；Sofia 2 螺旋菌 FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K252627Lyme-ID IgG 测试；Bio-ID800Inanovate, Inc.K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.K233367iDart莱姆病IgG免疫印迹试剂盒Id-Fish Technology, Inc.K230863宙斯索利纳斯伯氏螺旋体VlsE1/pepC10 IgG/IgM检测系统；宙斯索利纳斯伯氏螺旋体VlsE1/pepC10 IgG/IgM对照试剂盒Zeus Scientific K220016Viramed Borrela 全合一 ViraChip 检测试剂盒Viramed Biotech AG

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