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FDA 510(k)

三真實

K 號：K241676 · 2025-01-10

申請人Inflammatix, Inc.
決定日期2025-01-10
產品代碼PRE
諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)
決定相當於

器材摘要

TriVerity is the device name listed in this FDA 510(k) record. The listed applicant is Inflammatix, Inc.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K241676. The device is classified under product code PRE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TriVerity?

TriVerity is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Inflammatix, Inc.. The 510(k) number is K241676.

When did TriVerity receive FDA 510(k) clearance?

TriVerity received FDA 510(k) clearance on 2025-01-10, under 510(k) number K241676.

Who is the listed applicant for TriVerity?

The FDA 510(k) record lists Inflammatix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TriVerity?

The FDA product code for TriVerity is PRE.

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。

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相關器械（代碼：PRE）

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。

K232095九世細胞 RAPIDImmunexpress, Inc.K203748九世細胞 RAPIDImmunexpress, Inc.K163260九胞細胞實驗室Immunexpress, Inc.

官方來源

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