E. HISTOLYTICA QUIK CHEK
K号: K170728 · 2017-06-07
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决定日期2017-06-07
产品代码KHW
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器械摘要
E. HISTOLYTICA QUIK 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 2017-06-07 under 510(k) number K170728. The device is classified under product code KHW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the E. HISTOLYTICA QUIK CHEK?
E. HISTOLYTICA QUIK CHEK is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Techlab, Inc.. The 510(k) number is K170728.
When did E. HISTOLYTICA QUIK CHEK receive FDA 510(k) clearance?
E. HISTOLYTICA QUIK CHEK received FDA 510(k) clearance on 2017-06-07, under 510(k) number K170728.
Who is the listed applicant for E. HISTOLYTICA QUIK 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 E. HISTOLYTICA QUIK CHEK?
The FDA product code for E. HISTOLYTICA QUIK CHEK is KHW.
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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