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

    ALPCO/MERCODIA INSULIN ELISA

    K Number: K963911 · Decision Nov 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    26
    Applicant Total
    27
    Review Days
    32

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    Basic Information

    Device Name
    ALPCO/MERCODIA INSULIN ELISA
    K Number
    K963911
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1405
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Laboratory Products Co., Ltd.
    Date Received
    September 30, 1996
    Decision Date
    November 1, 1996
    Product Code
    CFP
    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
    CFP Radioimmunoassay, Immunoreactive Insulin

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