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

    QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)

    K Number: K051161 · Decision Nov 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    7
    Review Days
    201

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    Basic Information

    Device Name
    QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)
    K Number
    K051161
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quest Diagnostics, Inc.
    Date Received
    May 5, 2005
    Decision Date
    November 22, 2005
    Product Code
    DKZ
    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
    DKZ Enzyme Immunoassay, Amphetamine

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    Other Clearances by Quest Diagnostics, Inc.

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    K042726 QUEST DIAGNOSTICS HAIRCHECK-DT (PCP
    K042725 QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)
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