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FDA 510(k)

Quest Diagnostics HairCheck-DT (Cocaine)

K-Number: K152232 · 2016-11-18

ApplicantQuest Diagnostics Incorporated
Decision Date2016-11-18
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Quest Diagnostics HairCheck-DT (Cocaine) is a medical device manufactured by Quest Diagnostics Incorporated. It received FDA 510(k) clearance on 2016-11-18 under approval number K152232. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Quest Diagnostics Incorporated. The 510(k) number is K152232.

When was Quest Diagnostics HairCheck-DT (Cocaine) approved by the FDA?

Quest Diagnostics HairCheck-DT (Cocaine) received FDA 510(k) clearance on 2016-11-18, under approval number K152232.

What company makes Quest Diagnostics HairCheck-DT (Cocaine)?

Quest Diagnostics HairCheck-DT (Cocaine) is manufactured by Quest Diagnostics Incorporated.

What is the FDA product code for Quest Diagnostics HairCheck-DT (Cocaine)?

The FDA product code for Quest Diagnostics HairCheck-DT (Cocaine) is DIO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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