ImmuView S肺炎链球菌和L肺炎克雷伯菌尿液抗原检测
K号: K191184 · 2020-03-05
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决定日期2020-03-05
产品代码MJH
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器械摘要
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test is the device name listed in this FDA 510(k) record. The listed applicant is Ssi Diagnostica A/S. It received FDA 510(k) clearance on 2020-03-05 under 510(k) number K191184. The device is classified under product code MJH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ImmuView S pneumoniae and L pneumophila Urinary Antigen Test?
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test is a medical device that received FDA 510(k) clearance on 2020-03-05. The listed applicant is Ssi Diagnostica A/S. The 510(k) number is K191184.
When did ImmuView S pneumoniae and L pneumophila Urinary Antigen Test receive FDA 510(k) clearance?
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test received FDA 510(k) clearance on 2020-03-05, under 510(k) number K191184.
Who is the listed applicant for ImmuView S pneumoniae and L pneumophila Urinary Antigen Test?
The FDA 510(k) record lists Ssi Diagnostica A/S as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ImmuView S pneumoniae and L pneumophila Urinary Antigen Test?
The FDA product code for ImmuView S pneumoniae and L pneumophila Urinary Antigen Test is MJH.
相关临床试验
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相关器械（代码：MJH）
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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