H. PYLORI CHEK™
K号: K181400 · 2018-08-21
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决定日期2018-08-21
产品代码LYR
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决定实质等同
器械摘要
H. PYLORI CHEK™ is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 2018-08-21 under 510(k) number K181400. 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 H. PYLORI CHEK™?
H. PYLORI CHEK™ is a medical device that received FDA 510(k) clearance on 2018-08-21. The listed applicant is Techlab, Inc.. The 510(k) number is K181400.
When did H. PYLORI CHEK™ receive FDA 510(k) clearance?
H. PYLORI CHEK™ received FDA 510(k) clearance on 2018-08-21, under 510(k) number K181400.
Who is the listed applicant for H. PYLORI CHEK™?
The FDA 510(k) record lists Techlab, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for H. PYLORI CHEK™?
The FDA product code for H. PYLORI CHEK™ is LYR.
相关临床试验
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列明Techlab, 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。
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。
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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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