Quest Diagnostics HairCheck-DT (可卡因)
K号: K152232 · 2016-11-18
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决定日期2016-11-18
产品代码DIO
咨询委员会TX
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决定实质等同
器械摘要
Quest Diagnostics HairCheck-DT (Cocaine) is the device name listed in this FDA 510(k) record. The listed applicant is Quest Diagnostics Incorporated. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K152232. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Quest Diagnostics HairCheck-DT (Cocaine)?
Quest Diagnostics HairCheck-DT (Cocaine) is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Quest Diagnostics Incorporated. The 510(k) number is K152232.
When did Quest Diagnostics HairCheck-DT (Cocaine) receive FDA 510(k) clearance?
Quest Diagnostics HairCheck-DT (Cocaine) received FDA 510(k) clearance on 2016-11-18, under 510(k) number K152232.
Who is the listed applicant for Quest Diagnostics HairCheck-DT (Cocaine)?
The FDA 510(k) record lists Quest Diagnostics Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Quest Diagnostics HairCheck-DT (Cocaine)?
The FDA product code for Quest Diagnostics HairCheck-DT (Cocaine) is DIO.
相关临床试验
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相关器械（代码：DIO）
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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