FDA 510(k)

STA衛星Max®

K 號：K253658 · 2026-04-27

決定日期2026-04-27

產品代碼JPA

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

STA Satellite Max® is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica Stago, Inc.. It received FDA 510(k) clearance on 2026-04-27 under 510(k) number K253658. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STA Satellite Max®?

STA Satellite Max® is a medical device that received FDA 510(k) clearance on 2026-04-27. The listed applicant is Diagnostica Stago, Inc.. The 510(k) number is K253658.

When did STA Satellite Max® receive FDA 510(k) clearance?

STA Satellite Max® received FDA 510(k) clearance on 2026-04-27, under 510(k) number K253658.

Who is the listed applicant for STA Satellite Max®?

FDA 510(k) 記錄將 Diagnostica Stago, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for STA Satellite Max®?

The FDA product code for STA Satellite Max® is JPA.

其他以 Diagnostica Stago, Inc. 為申請人之記錄

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K260214STA® - 靈敏抗-Xa 液體

相關器械（代碼：JPA）

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。

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