Optilite 低水平白蛋白试剂盒
K号: K153560 · 2016-08-25
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决定日期2016-08-25
产品代码DCF
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器械摘要
Optilite Low Level Albumin Kit is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K153560. The device is classified under product code DCF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Optilite Low Level Albumin Kit?
Optilite Low Level Albumin Kit is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K153560.
When did Optilite Low Level Albumin Kit receive FDA 510(k) clearance?
Optilite Low Level Albumin Kit received FDA 510(k) clearance on 2016-08-25, under 510(k) number K153560.
Who is the listed applicant for Optilite Low Level Albumin Kit?
The FDA 510(k) record lists The Binding Site Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Optilite Low Level Albumin Kit?
The FDA product code for Optilite Low Level Albumin Kit is DCF.
相关临床试验
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列明The Binding Site Group , Ltd.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。
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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