EUROIMMUN 抗-BP230-CF ELISA（IgG）
K号: K193115 · 2020-09-17
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决定日期2020-09-17
产品代码OEG
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决定实质等同
器械摘要
EUROIMMUN Anti-BP230-CF 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 2020-09-17 under 510(k) number K193115. The device is classified under product code OEG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EUROIMMUN Anti-BP230-CF ELISA (IgG)?
EUROIMMUN Anti-BP230-CF ELISA (IgG) is a medical device that received FDA 510(k) clearance on 2020-09-17. The listed applicant is Euroimmun Us, Inc.. The 510(k) number is K193115.
When did EUROIMMUN Anti-BP230-CF ELISA (IgG) receive FDA 510(k) clearance?
EUROIMMUN Anti-BP230-CF ELISA (IgG) received FDA 510(k) clearance on 2020-09-17, under 510(k) number K193115.
Who is the listed applicant for EUROIMMUN Anti-BP230-CF 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-BP230-CF ELISA (IgG)?
The FDA product code for EUROIMMUN Anti-BP230-CF ELISA (IgG) is OEG.
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。
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。
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™ EUROPatternK172244EUROIMMUN 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）
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。
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