Vstrip幽门螺杆菌抗原快速检测
K号: K183573 · 2019-03-14
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决定日期2019-03-14
产品代码LYR
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器械摘要
Vstrip H. pylori Antigen Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is Panion & BF Biotech, Inc.. It received FDA 510(k) clearance on 2019-03-14 under 510(k) number K183573. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Vstrip H. pylori Antigen Rapid Test?
Vstrip H. pylori Antigen Rapid Test is a medical device that received FDA 510(k) clearance on 2019-03-14. The listed applicant is Panion & BF Biotech, Inc.. The 510(k) number is K183573.
When did Vstrip H. pylori Antigen Rapid Test receive FDA 510(k) clearance?
Vstrip H. pylori Antigen Rapid Test received FDA 510(k) clearance on 2019-03-14, under 510(k) number K183573.
Who is the listed applicant for Vstrip H. pylori Antigen Rapid Test?
The FDA 510(k) record lists Panion & BF Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Vstrip H. pylori Antigen Rapid Test?
The FDA product code for Vstrip H. pylori Antigen Rapid Test is LYR.
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相关器械（代码：LYR）
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
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