β2-微球蛋白
K号: K161297 · 2016-06-07
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决定日期2016-06-07
产品代码JZG
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器械摘要
Beta-2-Microglobulin 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 2016-06-07 under 510(k) number K161297. The device is classified under product code JZG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Beta-2-Microglobulin?
Beta-2-Microglobulin is a medical device that received FDA 510(k) clearance on 2016-06-07. The listed applicant is Beckman Coulter Ireland, Inc.. The 510(k) number is K161297.
When did Beta-2-Microglobulin receive FDA 510(k) clearance?
Beta-2-Microglobulin received FDA 510(k) clearance on 2016-06-07, under 510(k) number K161297.
Who is the listed applicant for Beta-2-Microglobulin?
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 Beta-2-Microglobulin?
The FDA product code for Beta-2-Microglobulin is JZG.
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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