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

    50NG/ML COCAINE METABOLITE CALIBRATOR

    K Number: K972835 · Decision Aug 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    122
    Applicant Total
    66
    Review Days
    28

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    Basic Information

    Device Name
    50NG/ML COCAINE METABOLITE CALIBRATOR
    K Number
    K972835
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Reagents, Inc.
    Date Received
    July 31, 1997
    Decision Date
    August 28, 1997
    Product Code
    DLJ
    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
    DLJ Calibrators, Drug Specific

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