BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACTIVE ANDROSTANEDIOL GLUCURONIDE

    K Number: K934751 · Decision Jan 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    9
    Applicant Total
    94
    Review Days
    98

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    Basic Information

    Device Name
    ACTIVE ANDROSTANEDIOL GLUCURONIDE
    K Number
    K934751
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1075
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Systems Laboratories, Inc.
    Date Received
    October 4, 1993
    Decision Date
    January 10, 1994
    Product Code
    CIZ
    Advisory Committee
    Clinical Chemistry
    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
    CIZ Radioimmunoassay, Androstenedione

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