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

    RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA

    K Number: K920981 · Decision Apr 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    189
    Applicant Total
    57
    Review Days
    46

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    Basic Information

    Device Name
    RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA
    K Number
    K920981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7290
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Diagnostic Technologies, Inc.
    Date Received
    March 2, 1992
    Decision Date
    April 17, 1992
    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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