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

    QUALITY CONTROL SYSTEM, SPECTRA

    K Number: K780097 · Decision Apr 24, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    11
    Applicant Total
    632
    Review Days
    95

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    Basic Information

    Device Name
    QUALITY CONTROL SYSTEM, SPECTRA
    K Number
    K780097
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9650
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    January 19, 1978
    Decision Date
    April 24, 1978
    Product Code
    KSF
    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
    KSF Kit, Quality Control For Blood Banking Reagents

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