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

    FERRITIN RADIOIMMUNOASSAY

    K Number: K792442 · Decision Dec 18, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    86
    Applicant Total
    44
    Review Days
    19

    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
    FERRITIN RADIOIMMUNOASSAY
    K Number
    K792442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Dade, Baxter Travenol Diagnostics, Inc.
    Date Received
    November 29, 1979
    Decision Date
    December 18, 1979
    Product Code
    DBF
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DBF Ferritin, Antigen, Antiserum, Control

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DBF), ordered by most recent decision date.

    LIAISON Ferritin

    FDA 510(k)
    FDA Class 2 ·Immunology

    Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor

    FDA 510(k)
    FDA Class 2 ·Immunology

    Atellica IM Ferritin Assay

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADVIA CHEMISTRY FERRITIN (FRT) METHOD

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    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
    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)
    K790571 QUIK-STAIN
    Search all 44 clearances from Dade, Baxter Travenol Diagnostics, Inc. →