Great Basin Shiga Toxin Direct Test
K号: K152955 · 2016-03-22
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决定日期2016-03-22
产品代码PCH
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器械摘要
Great Basin Shiga Toxin Direct Test is the device name listed in this FDA 510(k) record. The listed applicant is Great Basin Scientific, Inc.. It received FDA 510(k) clearance on 2016-03-22 under 510(k) number K152955. 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 Great Basin Shiga Toxin Direct Test?
Great Basin Shiga Toxin Direct Test is a medical device that received FDA 510(k) clearance on 2016-03-22. The listed applicant is Great Basin Scientific, Inc.. The 510(k) number is K152955.
When did Great Basin Shiga Toxin Direct Test receive FDA 510(k) clearance?
Great Basin Shiga Toxin Direct Test received FDA 510(k) clearance on 2016-03-22, under 510(k) number K152955.
Who is the listed applicant for Great Basin Shiga Toxin Direct Test?
The FDA 510(k) record lists Great Basin Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Great Basin Shiga Toxin Direct Test?
The FDA product code for Great Basin Shiga Toxin Direct Test is PCH.
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列明Great Basin Scientific, 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：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
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