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

    ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT

    K Number: K921868 · Decision Jan 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    623

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    Basic Information

    Device Name
    ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT
    K Number
    K921868
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1370
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Endocrine Sciences Products
    Date Received
    April 20, 1992
    Decision Date
    January 3, 1994
    Product Code
    CFL
    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
    CFL Radioimmunoassay, Human Growth Hormone

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