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K号: K161508 · 2017-01-09
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决定日期2017-01-09
产品代码DDB
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器械摘要
Ceruloplasmin is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter Ireland, Inc.. It received FDA 510(k) clearance on 2017-01-09 under 510(k) number K161508. The device is classified under product code DDB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Ceruloplasmin?
Ceruloplasmin is a medical device that received FDA 510(k) clearance on 2017-01-09. The listed applicant is Beckman Coulter Ireland, Inc.. The 510(k) number is K161508.
When did Ceruloplasmin receive FDA 510(k) clearance?
Ceruloplasmin received FDA 510(k) clearance on 2017-01-09, under 510(k) number K161508.
Who is the listed applicant for Ceruloplasmin?
The FDA 510(k) record lists Beckman Coulter Ireland, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ceruloplasmin?
The FDA product code for Ceruloplasmin is DDB.
相关临床试验
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列明Beckman Coulter Ireland, 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。
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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