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FDA 510(k)

抗中性球胞質抗體（乙醇固定）；抗中性球胞質抗體（福馬林固定）

K 號：K243776 · 2025-05-07

申請人Zeus Scientific
決定日期2025-05-07
產品代碼MOB
諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。
決定相當於

器材摘要

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.

常見問題

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) 記錄將宙斯科學列為申請人。這並不單獨確立設備製造商。

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Zeus Scientific 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261466Alegria Flash MPO；Alegria Flash PR3；Alegria Flash GBMK250814Alegria Flash SSA-60；Alegria Flash SSA-52；Alegria FLash SSBK250666Alegria Flash CTD屏幕K250408Alegria Flash ENA屏幕K231616ZEUS IFA™ nDNA測試系統，ZEUS dIFineK230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM 測試系統；ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM 控制組合

查看所有 7 項裝置 →

相關器械（代碼：MOB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261466Alegria Flash MPO；Alegria Flash PR3；Alegria Flash GBMZeus ScientificK172582歐瑞姆免疫 IFA 粒性細胞嵌合體™ EUROPattern 及歐瑞姆免疫 EUROPLUS 粒性細胞嵌合體™ EUROPatternEuroimmun Us, Inc.K172461AESKUSLIDES ANCA 酒精，AESKUSLIDES ANCA 福馬林Aesku.Diagnostics GmbH & Co. KGK173792EliA PR3s 免疫測試；EliA MPOs 免疫測試；EliA GBM 免疫測試Phadia ABK161258NOVA Lite DAPI ANCA 醇精套件，NOVA Lite DAPI ANCA 福尔马林套件Inova Diagnostics, Inc.

官方來源

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