FDA 510(k)

EUROIMMUN 抗组织转谷氨酰胺酶 ELISA（IgA），EUROIMMUN 抗组织转谷氨酰胺酶 ELISA（IgG）

K号: K183313 · 2019-02-28

决定日期2019-02-28

产品代码MVM

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决定实质等同

器械摘要

EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) is the device name listed in this FDA 510(k) record. The listed applicant is Euroimmun Us, Inc.. It received FDA 510(k) clearance on 2019-02-28 under 510(k) number K183313. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)?

EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) is a medical device that received FDA 510(k) clearance on 2019-02-28. The listed applicant is Euroimmun Us, Inc.. The 510(k) number is K183313.

When did EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) receive FDA 510(k) clearance?

EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) received FDA 510(k) clearance on 2019-02-28, under 510(k) number K183313.

Who is the listed applicant for EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)?

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

What is the FDA product code for EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)?

The FDA product code for EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) is MVM.

列明Euroimmun Us, 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。

K193115EUROIMMUN 抗-BP230-CF ELISA（IgG）K172582EUROIMMUN IFA 粒细胞镶嵌™ EUROPattern 和 EUROIMMUN EUROPLUS 粒细胞镶嵌™ EUROPattern K172252EUROIMMUN IFA：克氏锥虫敏感（抗-dsDNA）EUROPattern K172244EUROIMMUN IFA：克氏锥虫（抗-dsDNA）EUROPattern K172722抗伯氏疏螺旋体US EUROLINE-WB（IgM）K153308EUROIMMUN 抗西尼罗河病毒 ELISA（IgM）

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