ACE 血红蛋白A1c (HbA1c) 试剂
K号: K170623 · 2018-02-27
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决定日期2018-02-27
产品代码LCP
咨询委员会HE
请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
ACE Hemoglobin A1c (HbA1c) Reagent is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Wassermann Diagnostic Technologies, LLC. It received FDA 510(k) clearance on 2018-02-27 under 510(k) number K170623. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ACE Hemoglobin A1c (HbA1c) Reagent?
ACE Hemoglobin A1c (HbA1c) Reagent is a medical device that received FDA 510(k) clearance on 2018-02-27. The listed applicant is Alfa Wassermann Diagnostic Technologies, LLC. The 510(k) number is K170623.
When did ACE Hemoglobin A1c (HbA1c) Reagent receive FDA 510(k) clearance?
ACE Hemoglobin A1c (HbA1c) Reagent received FDA 510(k) clearance on 2018-02-27, under 510(k) number K170623.
Who is the listed applicant for ACE Hemoglobin A1c (HbA1c) Reagent?
The FDA 510(k) record lists Alfa Wassermann Diagnostic Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ACE Hemoglobin A1c (HbA1c) Reagent?
The FDA product code for ACE Hemoglobin A1c (HbA1c) Reagent is LCP.
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。
相关器械（代码：LCP）
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。
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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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