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

    QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)

    K Number: K042725 · Decision Jul 6, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    7
    Review Days
    278

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    Basic Information

    Device Name
    QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)
    K Number
    K042725
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Quest Diagnostics, Inc.
    Date Received
    October 1, 2004
    Decision Date
    July 6, 2005
    Product Code
    DJG
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DJG Enzyme Immunoassay, Opiates

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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
    K040257 QUEST DIAGNOSTICS HAIRCHECK-DT (THC)
    K023626 AML HAIRCHECK-DT (COCAINE)