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

    BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY

    K Number: K982714 · Decision Oct 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    86
    Applicant Total
    96
    Review Days
    79

    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
    BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
    K Number
    K982714
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Corp.
    Date Received
    August 4, 1998
    Decision Date
    October 22, 1998
    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 Bayer Corp.

    K Number Device Name
    K024062 ASCENSIA BREEZE BLOOD GLUCOSE METER
    K023944 BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
    K024017 BAYER ADVIA CENTAUR HER-2/NEU ASSAY
    K024234 ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
    K022288 COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
    K023584 ASCENSIA DEX 2 DIABETES CARE SYSTEM
    K020828 CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
    K021428 CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
    K020806 ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
    K013568 CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
    Search all 96 clearances from Bayer Corp. →