FDA 510(k)

核心代謝

K 號：K251157 · 2026-01-09

決定日期2026-01-09

產品代碼CIX

諮詢委員會CH

決定相當於

器材摘要

Core Metabolic is the device name listed in this FDA 510(k) record. The listed applicant is Truvian Health. It received FDA 510(k) clearance on 2026-01-09 under 510(k) number K251157. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Core Metabolic?

Core Metabolic is a medical device that received FDA 510(k) clearance on 2026-01-09. The listed applicant is Truvian Health. The 510(k) number is K251157.

When did Core Metabolic receive FDA 510(k) clearance?

Core Metabolic received FDA 510(k) clearance on 2026-01-09, under 510(k) number K251157.

Who is the listed applicant for Core Metabolic?

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 Core Metabolic?

The FDA product code for Core Metabolic is CIX.

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。

K251091脂質 K251074真肝健康檢測組合 K251058真兒童腎臟健康檢測組合；真分析器

相關器械（代碼：CIX）

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。

K203248Albumin BCG2Abbott Ireland Diagnostics Division K200898Medicon Hellas 藻膠蛋白，Medicon Hellas 钙，Medicon Hellas 肌酸酐，Medicon Hellas 尿素氮，Medicon Hellas 葡萄糖，Medicon Hellas 全總膽紅素，Medicon Hellas 直接膽紅素Medicon Hellas S.A K191316VITROS XT 化學產品 ALB-TP 製品Ortho-Clinical Diagnostics, Inc.K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400Biosystems S.A.

官方來源

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