FDA 510(k)

宙斯 IFA ANA HEp-2 测试系统，宙斯 dIFine

K号: K201956 · 2022-04-29

决定日期2022-04-29

产品代码DHN

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决定实质等同

器械摘要

Zeus IFA ANA HEp-2 Test System, Zeus dIFine is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K201956. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Zeus IFA ANA HEp-2 Test System, Zeus dIFine?

Zeus IFA ANA HEp-2 Test System, Zeus dIFine is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K201956.

When did Zeus IFA ANA HEp-2 Test System, Zeus dIFine receive FDA 510(k) clearance?

Zeus IFA ANA HEp-2 Test System, Zeus dIFine received FDA 510(k) clearance on 2022-04-29, under 510(k) number K201956.

Who is the listed applicant for Zeus IFA ANA HEp-2 Test System, Zeus dIFine?

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

What is the FDA product code for Zeus IFA ANA HEp-2 Test System, Zeus dIFine?

The FDA product code for Zeus IFA ANA HEp-2 Test System, Zeus dIFine is DHN.

列明Zeus Scientific, 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。

K191398宙斯ELISA伯氏螺旋体VlsE1/pepC10 IgG/IgM检测系统；宙斯ELISA伯氏疏螺旋体IgG检测系统 K191240宙斯ELISA伯氏螺旋体VlsE1/pepC10 IgG/IgM检测系统；宙斯ELISA伯氏疏螺旋体IgM检测系统 K190907宙斯ELISA伯氏疏螺旋体VlsE1/pepC10 IgG/IgM检测系统；宙斯ELISA伯氏疏螺旋体IgG/IgM检测系统

官方来源

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