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

    SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT

    K Number: K992799 · Decision Jun 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    19
    Applicant Total
    5
    Review Days
    293

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    Basic Information

    Device Name
    SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
    K Number
    K992799
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7250
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sangui Biotech, Inc.
    Date Received
    August 19, 1999
    Decision Date
    June 7, 2000
    Product Code
    GGT
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GGT Assay, Erythropoietin

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