FDA 510(k)

Alegria Flash SSA-60；Alegria Flash SSA-52；Alegria FLash SSB

K号: K250814 · 2026-05-08

决定日期2026-05-08

产品代码OBE

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

Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K250814. The device is classified under product code OBE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB?

Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Zeus Scientific. The 510(k) number is K250814.

When did Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB receive FDA 510(k) clearance?

Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB received FDA 510(k) clearance on 2026-05-08, under 510(k) number K250814.

Who is the listed applicant for Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB?

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 Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB?

The FDA product code for Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB is OBE.

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 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）K231616ZEUS IFA™ nDNA检测系统，ZEUS dIFine 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

查看所有 7 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。

器械摘要

常见问题

相关临床试验

列明Zeus Scientific为申报人的其他记录

官方来源