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FDA 510(k)

Diazyme 直接HbA1c测定（酶法，板载溶解），Diazyme 直接HbA1c测定校准器套装，Diazyme 直接HbA1c测定控制套装

K号: K160762 · 2016-11-21

申请人Diazyme Laboratories
决定日期2016-11-21
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

Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K160762. 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 Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set?

Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Diazyme Laboratories. The 510(k) number is K160762.

When did Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set receive FDA 510(k) clearance?

Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set received FDA 510(k) clearance on 2016-11-21, under 510(k) number K160762.

Who is the listed applicant for Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set?

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

What is the FDA product code for Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set?

The FDA product code for Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Diazyme Laboratories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。

K172992Diazyme EZ 维生素D测定K163418Diazyme DZ-Lite 总β-hCG 测试系统K162297Diazyme 前降钙素（PCT）测定，Diazyme 前降钙素（PCT）校准器套装，Diazyme 前降钙素（PCT）控制套装K153394Diazyme 人κ游离轻链测定，Diazyme 人λ游离轻链测定，Diazyme 人κ/λ游离轻链校准器，Diazyme 人κ/λ游离轻链校准器K161646Diazyme 叶酸测定，Diazyme 叶酸校准器套装，Diazyme 叶酸控制套装K161721Diazyme 维生素B12测定，Diazyme 维生素B12校准器套装，Diazyme 维生素B12控制套装

查看所有 8 个设备 →

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。

K221326Nova Allegro HbA1c检测，Nova Allegro分析仪Nova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 和 Alere Afinion™ AS100 分析仪Abbott Diagnostics Technologies ASK192987Aina HbA1c监测系统2Jana Care, Inc.K192369PixoTest POCT系统 - PixoTest POCT分析仪和PixoTest A1c测试套件Ixensor Co, Ltd.K183230OneDraw A1C测试系统Drawbridge Health, Inc.

官方来源

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