Quo-Test A1c 系统
K号: K180509 · 2019-02-16
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决定日期2019-02-16
产品代码LCP
咨询委员会HE
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器械摘要
Quo-Test A1c System is the device name listed in this FDA 510(k) record. The listed applicant is Ekf-Diagnostic GmbH. It received FDA 510(k) clearance on 2019-02-16 under 510(k) number K180509. 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 Quo-Test A1c System?
Quo-Test A1c System is a medical device that received FDA 510(k) clearance on 2019-02-16. The listed applicant is Ekf-Diagnostic GmbH. The 510(k) number is K180509.
When did Quo-Test A1c System receive FDA 510(k) clearance?
Quo-Test A1c System received FDA 510(k) clearance on 2019-02-16, under 510(k) number K180509.
Who is the listed applicant for Quo-Test A1c System?
The FDA 510(k) record lists Ekf-Diagnostic GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Quo-Test A1c System?
The FDA product code for Quo-Test A1c System is LCP.
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列明Ekf-Diagnostic GmbH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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