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

    ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL

    K Number: K974261 · Decision Dec 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    12
    Review Days
    28

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    Basic Information

    Device Name
    ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
    K Number
    K974261
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Biomedica, Inc.
    Date Received
    November 13, 1997
    Decision Date
    December 11, 1997
    Product Code
    LJK
    Advisory Committee
    Microbiology
    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
    LJK Antisera, If, Toxoplasma Gondii

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