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FDA 510(k)

EUROIMMUN IFA 粒细胞镶嵌™ EUROPattern 和 EUROIMMUN EUROPLUS 粒细胞镶嵌™ EUROPattern

K号: K172582 · 2018-05-24

申请人Euroimmun Us, Inc.
决定日期2018-05-24
产品代码MOB
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决定实质等同

器械摘要

EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ 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 2018-05-24 under 510(k) number K172582. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern?

EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Euroimmun Us, Inc.. The 510(k) number is K172582.

When did EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern receive FDA 510(k) clearance?

EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern received FDA 510(k) clearance on 2018-05-24, under 510(k) number K172582.

Who is the listed applicant for EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ 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 Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern?

The FDA product code for EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern is MOB.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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）K172244EUROIMMUN IFA：克氏锥虫（抗-dsDNA）EUROPatternK172252EUROIMMUN IFA：克氏锥虫敏感（抗-dsDNA）EUROPatternK172722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 →

相关器械（代码：MOB）

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。

K261466Alegria闪光MPO；Alegria闪光PR3；Alegria闪光GBMZeus ScientificK243776抗中性粒细胞胞浆抗体（乙醇固定）；抗中性粒细胞胞浆抗体（福尔马林固定）Zeus ScientificK172461AESKUSLIDES ANCA ̼, AESKUSLIDES ANCAAesku.Diagnostics GmbH & Co. KGK173792EliA PR3s 免疫测定；EliA MPOs 免疫测定；EliA GBM 免疫测定Phadia ABK161258NOVA Lite DAPI ANCA 乙醇试剂盒，NOVA Lite DAPI ANCA 甲醛试剂盒Inova Diagnostics, Inc.

官方来源

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