核心代谢
K号: K251157 · 2026-01-09
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决定日期2026-01-09
产品代码CIX
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Truvian Health为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：CIX）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K203248Albumin BCG2Abbott Ireland Diagnostics DivisionK200898Medicon Hellas 白蛋白，Medicon Hellas 钙，Medicon Hellas 肌酐，Medicon Hellas 尿素氮，Medicon Hellas 葡萄糖，Medicon Hellas 总胆红素，Medicon Hellas 直接胆红素Medicon Hellas S.AK191316VITROS XT 化学产品 ALB-TP 薄膜Ortho-Clinical Diagnostics, Inc.K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400Biosystems S.A.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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