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

    QUANTEX FERRITIN

    K Number: K040879 · Decision May 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    86
    Applicant Total
    321
    Review Days
    35

    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
    QUANTEX FERRITIN
    K Number
    K040879
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    April 5, 2004
    Decision Date
    May 10, 2004
    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 Instrumentation Laboratory CO

    K Number Device Name
    K221359 ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
    K223187 HemosIL Liquid Anti-Xa
    K223090 GEM Premier ChemSTAT
    K223402 HemosIL von Willebrand Factor Antigen
    K213464 HemosIL Liquid Anti-Xa
    K213426 HemosIL ReadiPlasTin
    K203790 GEM Premier 5000
    DEN190032 HemosIL Liquid Anti-Xa
    K200033 HemosIL von Willebrand Factor Antigen
    K183549 GEM Premier ChemSTAT
    Search all 321 clearances from Instrumentation Laboratory CO →