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

    QUEST DIAGNOSTICS HAIRCHECK-DT (PCP

    K Number: K042726 · Decision Jul 28, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    87
    Applicant Total
    7
    Review Days
    300

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    Basic Information

    Device Name
    QUEST DIAGNOSTICS HAIRCHECK-DT (PCP
    K Number
    K042726
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quest Diagnostics, Inc.
    Date Received
    October 1, 2004
    Decision Date
    July 28, 2005
    Product Code
    LCM
    Advisory Committee
    Unknown
    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
    LCM Enzyme Immunoassay, Phencyclidine

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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)
    K042725 QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)
    K040257 QUEST DIAGNOSTICS HAIRCHECK-DT (THC)
    K023626 AML HAIRCHECK-DT (COCAINE)