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

    ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR

    K Number: K914225 · Decision Nov 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    52
    Applicant Total
    253
    Review Days
    63

    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
    ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR
    K Number
    K914225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5630
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    September 20, 1991
    Decision Date
    November 22, 1991
    Product Code
    JZG
    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
    JZG System, Test, Beta-2-Microglobulin Immunological

    Similar 510(k) Clearances

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

    Beta-2-Microglobulin

    FDA 510(k)
    FDA Class 2 ·Immunology

    HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    HUMAN BETA-2 MICROGLOBULIN KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307

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

    Other Clearances by E.I. Dupont DE Nemours & Co., Inc.

    K Number Device Name
    K951851 ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
    K953725 CRONEX RADIATION THERAPY VERIFICATION CASSETTE
    K953724 CRONEX RADIATION THERAPY CASSETTE
    K951441 DUPONT ACA DIGOXIN (DGN A) METHOD
    K950137 URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950136 URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950181 URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950135 URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950182 URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE
    K950134 URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
    Search all 253 clearances from E.I. Dupont DE Nemours & Co., Inc. →