科博斯HbA1c检测，科博斯b 101系统
K号: K163633 · 2017-07-28
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决定日期2017-07-28
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
cobas HbA1c Test, cobas b 101 system is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations. It received FDA 510(k) clearance on 2017-07-28 under 510(k) number K163633. 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 cobas HbA1c Test, cobas b 101 system?
cobas HbA1c Test, cobas b 101 system is a medical device that received FDA 510(k) clearance on 2017-07-28. The listed applicant is Roche Diagnostics Operations. The 510(k) number is K163633.
When did cobas HbA1c Test, cobas b 101 system receive FDA 510(k) clearance?
cobas HbA1c Test, cobas b 101 system received FDA 510(k) clearance on 2017-07-28, under 510(k) number K163633.
Who is the listed applicant for cobas HbA1c Test, cobas b 101 system?
The FDA 510(k) record lists Roche Diagnostics Operations as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for cobas HbA1c Test, cobas b 101 system?
The FDA product code for cobas HbA1c Test, cobas b 101 system is LCP.
相关临床试验
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列明Roche Diagnostics Operations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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