FDA 510(k)

Gold Standard Diagnostics 摩氏菌 IgM ELISA 测试试剂盒

K号: K203295 · 2021-03-22

决定日期2021-03-22

产品代码LSR

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决定实质等同

器械摘要

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit is the device name listed in this FDA 510(k) record. The listed applicant is Gold Standard Diagnostics. It received FDA 510(k) clearance on 2021-03-22 under 510(k) number K203295. 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 Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit?

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit is a medical device that received FDA 510(k) clearance on 2021-03-22. The listed applicant is Gold Standard Diagnostics. The 510(k) number is K203295.

When did Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit receive FDA 510(k) clearance?

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit received FDA 510(k) clearance on 2021-03-22, under 510(k) number K203295.

Who is the listed applicant for Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit?

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

What is the FDA product code for Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit?

The FDA product code for Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit is LSR.

列明Gold Standard 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。

K203296Gold Standard Diagnostics 摩氏菌 IgG ELISA 测试试剂盒 K203292Gold Standard Diagnostics 摩氏菌 IgG/IgM ELISA 测试试剂盒 K203289Gold Standard Diagnostics 摩氏菌 VlsE-OspC IgG/IgM ELISA 测试试剂盒 K200025Gold Standard Diagnostics 摩氏菌 IgG ELISA 测试试剂盒 K200023Gold Standard Diagnostics 摩氏菌 IgM ELISA 测试试剂盒 K180264Gold Standard Diagnostics 摩氏菌 IgG/IgM ELISA 测试试剂盒

查看所有 7 个设备 →

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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