BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IMMUFUGE DISP. LINER

    K Number: K780281 · Decision Mar 2, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    0
    Applicant Total
    44
    Review Days
    9

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    IMMUFUGE DISP. LINER
    K Number
    K780281
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.9275
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Dade, Baxter Travenol Diagnostics, Inc.
    Date Received
    February 21, 1978
    Decision Date
    March 2, 1978
    Product Code
    KSO
    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
    KSO Centrifuge, Blood-Bank For In Vitro Diagnostic Use

    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
    K790767 IMMU-TEK AUTOMATIC CENTRIFUGE
    K790776 DADE LOW IONIC STRENGTH SOLUITION (LISS)
    Search all 44 clearances from Dade, Baxter Travenol Diagnostics, Inc. →