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

    BIOCHECK FERRITIN ELISA MODEL BC-1025

    K Number: K992517 · Decision Sep 24, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    86
    Applicant Total
    14
    Review Days
    58

    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
    BIOCHECK FERRITIN ELISA MODEL BC-1025
    K Number
    K992517
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biocheck, Inc.
    Date Received
    July 28, 1999
    Decision Date
    September 24, 1999
    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 Biocheck, Inc.

    K Number Device Name
    K041619 BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
    K040030 BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114
    K022660 BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
    K013062 BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
    K003851 BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119
    K002294 BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
    K001022 BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061
    K992528 BIOCHECK IGE ELISA, MODEL BC-1035
    K991741 BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
    K991146 TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001
    Search all 14 clearances from Biocheck, Inc. →