FDA 510(k)

真肝健康檢測組合

K 號：K251074 · 2025-12-19

決定日期2025-12-19

產品代碼CJE

諮詢委員會CH

決定相當於

器材摘要

Tru Liver Health Test Panel is the device name listed in this FDA 510(k) record. The listed applicant is Truvian Health. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K251074. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tru Liver Health Test Panel?

Tru Liver Health Test Panel is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Truvian Health. The 510(k) number is K251074.

When did Tru Liver Health Test Panel receive FDA 510(k) clearance?

Tru Liver Health Test Panel received FDA 510(k) clearance on 2025-12-19, under 510(k) number K251074.

Who is the listed applicant for Tru Liver Health Test Panel?

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

What is the FDA product code for Tru Liver Health Test Panel?

The FDA product code for Tru Liver Health Test Panel is CJE.

其他以 Truvian Health 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。

K251157核心代謝 K251091脂質 K251058真兒童腎臟健康檢測組合；真分析器

相關器械（代碼：CJE）

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。

K240468鹼性磷酸鹽Abbott Laboratories Diagnostics Division K223317鹼性磷酸鹽2Abbott Ireland Diagnostics Division K191245裕米森C1200 ALP，裕米森C1200白蛋白HORIBA ABX SAS K171971全套代謝檢查、skyla 臨床化學分析儀、Minicare C300 臨床化學分析儀Lite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)K162275Randox RX Daytona Plus 鋁鹼磷酸鹽酶（ALP）Randox Laboratories Limited

官方來源

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