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

    FERRITIN MAB SOLID PHASE COMPONENT SYSTEM

    K Number: K870570 · Decision Mar 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    86
    Applicant Total
    632
    Review Days
    30

    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 MAB SOLID PHASE COMPONENT SYSTEM
    K Number
    K870570
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    February 10, 1987
    Decision Date
    March 12, 1987
    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 Bd Becton Dickinson Vacutainer Systems Preanalytic

    K Number Device Name
    K003062 BACTEC MGIT 960 SIR KITS
    K003553 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
    K003461 BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
    K002938 B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16
    K001364 BD DIRECTIGEN FLU A+B
    K000762 MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
    K000829 GATIFLOXACIN, 5 UG, BBL SENSI-DISC
    K993186 SYNERCID, 15 UG, BBL SENSI-DISC
    K992734 BECTON DICKINSON SYRINGE
    K991551 VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
    Search all 632 clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic →