FDA 510(k)

Lyme B. burgdorferi (IgG) MarStripe 测试

K号: K163095 · 2017-02-01

决定日期2017-02-01

产品代码LSR

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决定实质等同

器械摘要

Lyme B. burgdorferi (IgG) MarStripe Test is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Biotech. It received FDA 510(k) clearance on 2017-02-01 under 510(k) number K163095. 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 Lyme B. burgdorferi (IgG) MarStripe Test?

Lyme B. burgdorferi (IgG) MarStripe Test is a medical device that received FDA 510(k) clearance on 2017-02-01. The listed applicant is Trinity Biotech. The 510(k) number is K163095.

When did Lyme B. burgdorferi (IgG) MarStripe Test receive FDA 510(k) clearance?

Lyme B. burgdorferi (IgG) MarStripe Test received FDA 510(k) clearance on 2017-02-01, under 510(k) number K163095.

Who is the listed applicant for Lyme B. burgdorferi (IgG) MarStripe Test?

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

What is the FDA product code for Lyme B. burgdorferi (IgG) MarStripe Test?

The FDA product code for Lyme B. burgdorferi (IgG) MarStripe Test is LSR.

列明Trinity Biotech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。

K172254Lyme B. burgdorferi (IgM) MarStripe 测试

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。

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官方来源

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