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

    QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA

    K Number: K080381 · Decision Jun 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    48
    Applicant Total
    7
    Review Days
    133

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    Basic Information

    Device Name
    QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
    K Number
    K080381
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quest Diagnostics, Inc.
    Date Received
    February 13, 2008
    Decision Date
    June 25, 2008
    Product Code
    LAF
    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
    LAF Gas Chromatography, Methamphetamine

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    Other Clearances by Quest Diagnostics, Inc.

    K Number Device Name
    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)
    K023626 AML HAIRCHECK-DT (COCAINE)