BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AML HAIRCHECK-DT (COCAINE)

    K Number: K023626 · Decision Sep 29, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    7
    Review Days
    335

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    Basic Information

    Device Name
    AML HAIRCHECK-DT (COCAINE)
    K Number
    K023626
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Quest Diagnostics, Inc.
    Date Received
    October 29, 2002
    Decision Date
    September 29, 2003
    Product Code
    DIO
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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    Other Clearances by Quest Diagnostics, Inc.

    K Number Device Name
    K080381 QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
    K062929 QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA
    K051161 QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)
    K042726 QUEST DIAGNOSTICS HAIRCHECK-DT (PCP
    K042725 QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)
    K040257 QUEST DIAGNOSTICS HAIRCHECK-DT (THC)