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

    MICROFILTRATION SET MF10

    K Number: K770253 · Decision Apr 5, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    55

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    Basic Information

    Device Name
    MICROFILTRATION SET MF10
    K Number
    K770253
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Biotest-Serum-Institut
    Date Received
    February 9, 1977
    Decision Date
    April 5, 1977
    Product Code
    CAK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAK Microfilter, Blood Transfusion

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    Other Clearances by Biotest-Serum-Institut

    K Number Device Name
    K812076 ANTI-GM & ANTI-KM TYPING SERUMS