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FDA 510(k)

AML HAIRCHECK-DT (COCAINE)

K-Number: K023626 · 2003-09-29

ApplicantQuest Diagnostics, Inc.
Decision Date2003-09-29
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AML HAIRCHECK-DT (COCAINE) 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 2003-09-29 under 510(k) number K023626. 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 AML HAIRCHECK-DT (COCAINE)?

AML HAIRCHECK-DT (COCAINE) is a medical device that received FDA 510(k) clearance on 2003-09-29. The listed applicant is Quest Diagnostics, Inc.. The 510(k) number is K023626.

When did AML HAIRCHECK-DT (COCAINE) receive FDA 510(k) clearance?

AML HAIRCHECK-DT (COCAINE) received FDA 510(k) clearance on 2003-09-29, under 510(k) number K023626.

Who is the listed applicant for AML HAIRCHECK-DT (COCAINE)?

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 AML HAIRCHECK-DT (COCAINE)?

The FDA product code for AML HAIRCHECK-DT (COCAINE) is DIO.

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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)K040257QUEST DIAGNOSTICS HAIRCHECK-DT (THC)

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Related Devices (Code: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation

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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