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

    IMMU-TEK AUTOMATIC CENTRIFUGE

    K Number: K790767 · Decision May 23, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    0
    Applicant Total
    44
    Review Days
    34

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    Basic Information

    Device Name
    IMMU-TEK AUTOMATIC CENTRIFUGE
    K Number
    K790767
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9285
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Dade, Baxter Travenol Diagnostics, Inc.
    Date Received
    April 19, 1979
    Decision Date
    May 23, 1979
    Product Code
    KSN
    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
    KSN Centrifuge, Cell-Washing, Automated For Immuno-Hematology

    Other Clearances by Dade, Baxter Travenol Diagnostics, Inc.

    K Number Device Name
    K800296 WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3
    K792606 WHOLE BLOOD PLATELET CONTROL NORMAL,
    K792723 BLOOD FLUID FILTERS
    K792607 T3 UPTAKE (T3U) REAGENTS
    K792443 TSH RADIOIMMUNOASSAY
    K792442 FERRITIN RADIOIMMUNOASSAY
    K791922 HARLECO BRAND CLINICARD LIPASE TEST SET
    K792183 DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
    K790776 DADE LOW IONIC STRENGTH SOLUITION (LISS)
    K790571 QUIK-STAIN
    Search all 44 clearances from Dade, Baxter Travenol Diagnostics, Inc. →