FDA 510(k)

EUROIMMUN IFA：克氏锥虫敏感（抗-dsDNA）EUROPattern

K号: K172252 · 2018-04-20

决定日期2018-04-20

产品代码KTL

咨询委员会抱歉，您提供的信息不完整，无法进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern 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 2018-04-20 under 510(k) number K172252. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern?

EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Euroimmun Us, Inc.. The 510(k) number is K172252.

When did EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern receive FDA 510(k) clearance?

EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern received FDA 510(k) clearance on 2018-04-20, under 510(k) number K172252.

Who is the listed applicant for EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern?

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 IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern?

The FDA product code for EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern is KTL.

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）K183313EUROIMMUN 抗组织转谷氨酰胺酶 ELISA（IgA），EUROIMMUN 抗组织转谷氨酰胺酶 ELISA（IgG）K172582EUROIMMUN IFA 粒细胞镶嵌™ EUROPattern 和 EUROIMMUN EUROPLUS 粒细胞镶嵌™ 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）

查看所有 8 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。