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

    SANGUI BIOTECH, INC. CALCITONIN ELISA KIT

    K Number: K982491 · Decision Sep 3, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    19
    Applicant Total
    5
    Review Days
    48

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    Basic Information

    Device Name
    SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
    K Number
    K982491
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1140
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sangui Biotech, Inc.
    Date Received
    July 17, 1998
    Decision Date
    September 3, 1998
    Product Code
    JKR
    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
    JKR Radioimmunoassay, Calcitonin

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