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

    ACCURUN 121 HAV IGM POSITIVE CONTROL

    K Number: K971657 · Decision Aug 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    12
    Review Days
    98

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    Basic Information

    Device Name
    ACCURUN 121 HAV IGM POSITIVE CONTROL
    K Number
    K971657
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Boston Biomedica, Inc.
    Date Received
    May 6, 1997
    Decision Date
    August 12, 1997
    Product Code
    JJY
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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