FDA 510(k)

Quest Diagnostics 髮檢-DT（可卡因）

K 號：K152232 · 2016-11-18

決定日期2016-11-18

產品代碼DIO

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決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：DIO）

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官方來源

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