Lucica 糖化白蛋白-L
K号: K170147 · 2017-10-12
广告
决定日期2017-10-12
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
Lucica Glycated Albumin-L is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Kasei Pharma Corporation. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K170147. 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 Lucica Glycated Albumin-L?
Lucica Glycated Albumin-L is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Asahi Kasei Pharma Corporation. The 510(k) number is K170147.
When did Lucica Glycated Albumin-L receive FDA 510(k) clearance?
Lucica Glycated Albumin-L received FDA 510(k) clearance on 2017-10-12, under 510(k) number K170147.
Who is the listed applicant for Lucica Glycated Albumin-L?
The FDA 510(k) record lists Asahi Kasei Pharma Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lucica Glycated Albumin-L?
The FDA product code for Lucica Glycated Albumin-L 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。
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
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。
广告