A1C EZ 糖化血红蛋白分析系统
K号: K161533 · 2017-06-16
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决定日期2017-06-16
产品代码LCP
咨询委员会HE
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决定实质等同
器械摘要
A1C EZ Glycohemoglobin Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Biohermes Co., Ltd.. It received FDA 510(k) clearance on 2017-06-16 under 510(k) number K161533. 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 A1C EZ Glycohemoglobin Analysis System?
A1C EZ Glycohemoglobin Analysis System is a medical device that received FDA 510(k) clearance on 2017-06-16. The listed applicant is Biohermes Co., Ltd.. The 510(k) number is K161533.
When did A1C EZ Glycohemoglobin Analysis System receive FDA 510(k) clearance?
A1C EZ Glycohemoglobin Analysis System received FDA 510(k) clearance on 2017-06-16, under 510(k) number K161533.
Who is the listed applicant for A1C EZ Glycohemoglobin Analysis System?
The FDA 510(k) record lists Biohermes Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for A1C EZ Glycohemoglobin Analysis System?
The FDA product code for A1C EZ Glycohemoglobin Analysis System is LCP.
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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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