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

    TRISEDTA-BORATE ELECTROPHORESIS FILM AGA

    K Number: K790943 · Decision Jun 22, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    4
    Applicant Total
    111
    Review Days
    35

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    Basic Information

    Device Name
    TRISEDTA-BORATE ELECTROPHORESIS FILM AGA
    K Number
    K790943
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Corning Medical & Scientific
    Date Received
    May 18, 1979
    Decision Date
    June 22, 1979
    Product Code
    GHS
    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
    GHS Assay, Carboxyhemoglobin

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