EntericBio Dx 测定
K号: K182703 · 2019-06-19
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决定日期2019-06-19
产品代码PCH
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器械摘要
EntericBio Dx Assay is the device name listed in this FDA 510(k) record. The listed applicant is Serosep , Ltd.. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K182703. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EntericBio Dx Assay?
EntericBio Dx Assay is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Serosep , Ltd.. The 510(k) number is K182703.
When did EntericBio Dx Assay receive FDA 510(k) clearance?
EntericBio Dx Assay received FDA 510(k) clearance on 2019-06-19, under 510(k) number K182703.
Who is the listed applicant for EntericBio Dx Assay?
The FDA 510(k) record lists Serosep , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EntericBio Dx Assay?
The FDA product code for EntericBio Dx Assay is PCH.
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。
相关器械（代码：PCH）
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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