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

    SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA

    K Number: K974306 · Decision Dec 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    85
    Applicant Total
    5
    Review Days
    36

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    Basic Information

    Device Name
    SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA
    K Number
    K974306
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1545
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sangui Biotech, Inc.
    Date Received
    November 17, 1997
    Decision Date
    December 23, 1997
    Product Code
    CEW
    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
    CEW Radioimmunoassay, Parathyroid Hormone

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