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FDA 510(k)

QUEST DIAGNOSTICS HAIRCHECK-DT (THC)

K-Number: K040257 · 2004-06-14

ApplicantQuest Diagnostics, Inc.
Decision Date2004-06-14
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUEST DIAGNOSTICS HAIRCHECK-DT (THC) is the device name listed in this FDA 510(k) record. The listed applicant is Quest Diagnostics, Inc.. It received FDA 510(k) clearance on 2004-06-14 under 510(k) number K040257. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUEST DIAGNOSTICS HAIRCHECK-DT (THC)?

QUEST DIAGNOSTICS HAIRCHECK-DT (THC) is a medical device that received FDA 510(k) clearance on 2004-06-14. The listed applicant is Quest Diagnostics, Inc.. The 510(k) number is K040257.

When did QUEST DIAGNOSTICS HAIRCHECK-DT (THC) receive FDA 510(k) clearance?

QUEST DIAGNOSTICS HAIRCHECK-DT (THC) received FDA 510(k) clearance on 2004-06-14, under 510(k) number K040257.

Who is the listed applicant for QUEST DIAGNOSTICS HAIRCHECK-DT (THC)?

The FDA 510(k) record lists Quest Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUEST DIAGNOSTICS HAIRCHECK-DT (THC)?

The FDA product code for QUEST DIAGNOSTICS HAIRCHECK-DT (THC) is LDJ.

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Other records listing Quest Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K080381QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIAK062929QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIAK051161QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)K042726QUEST DIAGNOSTICS HAIRCHECK-DT (PCPK042725QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)K023626AML HAIRCHECK-DT (COCAINE)

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Related Devices (Code: LDJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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