Alere Afinion HbA1c和ACR在Afinion 2分析仪上
K号: K171650 · 2017-11-21
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决定日期2017-11-21
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
Alere Afinion HbA1c and ACR on Afinion 2 analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Rapid Diagnostics. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K171650. 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 Alere Afinion HbA1c and ACR on Afinion 2 analyzer?
Alere Afinion HbA1c and ACR on Afinion 2 analyzer is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Abbott Rapid Diagnostics. The 510(k) number is K171650.
When did Alere Afinion HbA1c and ACR on Afinion 2 analyzer receive FDA 510(k) clearance?
Alere Afinion HbA1c and ACR on Afinion 2 analyzer received FDA 510(k) clearance on 2017-11-21, under 510(k) number K171650.
Who is the listed applicant for Alere Afinion HbA1c and ACR on Afinion 2 analyzer?
The FDA 510(k) record lists Abbott Rapid Diagnostics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Alere Afinion HbA1c and ACR on Afinion 2 analyzer?
The FDA product code for Alere Afinion HbA1c and ACR on Afinion 2 analyzer 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。
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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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