TRI-COMBO 寄生虫筛查器
K号: K171078 · 2017-07-10
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决定日期2017-07-10
产品代码MHJ
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决定实质等同
器械摘要
TRI-COMBO PARASITE SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 2017-07-10 under 510(k) number K171078. The device is classified under product code MHJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TRI-COMBO PARASITE SCREEN?
TRI-COMBO PARASITE SCREEN is a medical device that received FDA 510(k) clearance on 2017-07-10. The listed applicant is Techlab, Inc.. The 510(k) number is K171078.
When did TRI-COMBO PARASITE SCREEN receive FDA 510(k) clearance?
TRI-COMBO PARASITE SCREEN received FDA 510(k) clearance on 2017-07-10, under 510(k) number K171078.
Who is the listed applicant for TRI-COMBO PARASITE SCREEN?
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 TRI-COMBO PARASITE SCREEN?
The FDA product code for TRI-COMBO PARASITE SCREEN is MHJ.
相关临床试验
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。
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。
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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