FDA 510(k)

ZEUS IFA™ nDNA检测系统，ZEUS dIFine

K号: K231616 · 2023-08-31

决定日期2023-08-31

产品代码KTL

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决定实质等同

器械摘要

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K231616. 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 ZEUS IFA(TM) nDNA Test System, ZEUS dIFine?

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Zeus Scientific. The 510(k) number is K231616.

When did ZEUS IFA(TM) nDNA Test System, ZEUS dIFine receive FDA 510(k) clearance?

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine received FDA 510(k) clearance on 2023-08-31, under 510(k) number K231616.

Who is the listed applicant for ZEUS IFA(TM) nDNA Test System, ZEUS dIFine?

FDA 510(k)记录显示宙斯科学公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for ZEUS IFA(TM) nDNA Test System, ZEUS dIFine?

The FDA product code for ZEUS IFA(TM) nDNA Test System, ZEUS dIFine is KTL.

列明Zeus Scientific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。

K261466Alegria闪光MPO；Alegria闪光PR3；Alegria闪光GBM K250814Alegria Flash SSA-60；Alegria Flash SSA-52；Alegria FLash SSB K250666Alegria Flash CTD屏幕 K250408Alegria Flash ENA屏幕 K243776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）K230863宙斯索利纳斯伯氏螺旋体VlsE1/pepC10 IgG/IgM检测系统；宙斯索利纳斯伯氏螺旋体VlsE1/pepC10 IgG/IgM对照试剂盒

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官方来源

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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。