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FDA 510(k)

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）

K号: K243776 · 2025-05-07

申请人Zeus Scientific
决定日期2025-05-07
产品代码MOB
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决定实质等同

器械摘要

Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific. It received FDA 510(k) clearance on 2025-05-07 under 510(k) number K243776. 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 Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)?

Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) is a medical device that received FDA 510(k) clearance on 2025-05-07. The listed applicant is Zeus Scientific. The 510(k) number is K243776.

When did Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) receive FDA 510(k) clearance?

Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) received FDA 510(k) clearance on 2025-05-07, under 510(k) number K243776.

Who is the listed applicant for Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)?

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 Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)?

The FDA product code for Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) 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GBMK250814Alegria Flash SSA-60；Alegria Flash SSA-52；Alegria FLash SSBK250666Alegria Flash CTD屏幕K250408Alegria Flash ENA屏幕K231616ZEUS IFA™ nDNA检测系统，ZEUS dIFineK230863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 →

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 ScientificK172582EUROIMMUN IFA 粒细胞镶嵌™ EUROPattern 和 EUROIMMUN EUROPLUS 粒细胞镶嵌™ EUROPatternEuroimmun Us, Inc.K172461AESKUSLIDES 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

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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