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

    SPECTROLYSE FACTOR VII:C

    K Number: K934584 · Decision Dec 6, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    189
    Applicant Total
    1
    Review Days
    74

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    Basic Information

    Device Name
    SPECTROLYSE FACTOR VII:C
    K Number
    K934584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7290
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Meditech, Inc.
    Date Received
    September 23, 1993
    Decision Date
    December 6, 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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