SensiTox C. difficile 毒素测试
K号: K193490 · 2021-07-08
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决定日期2021-07-08
产品代码LLH
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器械摘要
SensiTox C. difficile Toxin Test is the device name listed in this FDA 510(k) record. The listed applicant is First Light Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K193490. The device is classified under product code LLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SensiTox C. difficile Toxin Test?
SensiTox C. difficile Toxin Test is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is First Light Diagnostics, Inc.. The 510(k) number is K193490.
When did SensiTox C. difficile Toxin Test receive FDA 510(k) clearance?
SensiTox C. difficile Toxin Test received FDA 510(k) clearance on 2021-07-08, under 510(k) number K193490.
Who is the listed applicant for SensiTox C. difficile Toxin Test?
The FDA 510(k) record lists First Light Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SensiTox C. difficile Toxin Test?
The FDA product code for SensiTox C. difficile Toxin Test is LLH.
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列明First Light Diagnostics, 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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