FDA 510(k)

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

K 號：K250814 · 2026-05-08

決定日期2026-05-08

產品代碼OBE

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

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.

常見問題

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) 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 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.

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 GBM K250666Alegria Flash CTD屏幕 K250408Alegria Flash ENA屏幕 K243776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）K231616ZEUS IFA™ nDNA測試系統，ZEUS dIFine K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM 測試系統；ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM 控制組合

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官方來源

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