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

    HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY

    K Number: K930235 · Decision Sep 2, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    189
    Applicant Total
    2
    Review Days
    240

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    Basic Information

    Device Name
    HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY
    K Number
    K930235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7290
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Technidyne Corp.
    Date Received
    January 5, 1993
    Decision Date
    September 2, 1993
    Product Code
    GGP
    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
    GGP Test, Qualitative And Quantitative Factor Deficiency

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    Other Clearances by Technidyne Corp.

    K Number Device Name
    K930068 HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION