OneDraw A1C测试系统
K号: K183230 · 2019-08-15
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决定日期2019-08-15
产品代码LCP
咨询委员会HE
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器械摘要
OneDraw A1C Test System is the device name listed in this FDA 510(k) record. The listed applicant is Drawbridge Health, Inc.. It received FDA 510(k) clearance on 2019-08-15 under 510(k) number K183230. 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 OneDraw A1C Test System?
OneDraw A1C Test System is a medical device that received FDA 510(k) clearance on 2019-08-15. The listed applicant is Drawbridge Health, Inc.. The 510(k) number is K183230.
When did OneDraw A1C Test System receive FDA 510(k) clearance?
OneDraw A1C Test System received FDA 510(k) clearance on 2019-08-15, under 510(k) number K183230.
Who is the listed applicant for OneDraw A1C Test System?
The FDA 510(k) record lists Drawbridge Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OneDraw A1C Test System?
The FDA product code for OneDraw A1C Test System is LCP.
相关临床试验
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列明Drawbridge Health, Inc.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：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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