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FDA 510(k)

QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)

K-Number: K051161 · 2005-11-22

ApplicantQuest Diagnostics, Inc.
Decision Date2005-11-22
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) 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 2005-11-22 under 510(k) number K051161. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) is a medical device that received FDA 510(k) clearance on 2005-11-22. The listed applicant is Quest Diagnostics, Inc.. The 510(k) number is K051161.

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

QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) received FDA 510(k) clearance on 2005-11-22, under 510(k) number K051161.

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

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 (AMPHETAMINES)?

The FDA product code for QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) is DKZ.

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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 EIAK042726QUEST DIAGNOSTICS HAIRCHECK-DT (PCPK042725QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)K040257QUEST DIAGNOSTICS HAIRCHECK-DT (THC)K023626AML HAIRCHECK-DT (COCAINE)

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Related Devices (Code: DKZ)

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.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas MedicalK182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.

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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