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

    PLASMAPOOLER

    K Number: K801219 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    15
    Applicant Total
    6
    Review Days
    163

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    Basic Information

    Device Name
    PLASMAPOOLER
    K Number
    K801219
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9100
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    North American Biologicals, Inc.
    Date Received
    May 21, 1980
    Decision Date
    October 31, 1980
    Product Code
    KSR
    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
    KSR Container, Empty, For Collection & Processing Of Blood & Blood Components

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    Other Clearances by North American Biologicals, Inc.

    K Number Device Name
    K820301 PLASMA POOLER HEAT SEALER
    K801425 RH CONTROL
    K781895 BLOOD GROUP SUBSTANCE B
    K781862 BLOOD GROUP SUBSTANCE A
    K781896 BLOOD GROUP SUBSTANCE A,B