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

    RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI

    K Number: K851282 · Decision May 24, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    19
    Review Days
    53

    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
    RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI
    K Number
    K851282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5620
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Cooper Biomedical, Inc.
    Date Received
    April 1, 1985
    Decision Date
    May 24, 1985
    Product Code
    DEB
    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
    DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    ALPHA-2 MACROGLOBULIN TEST RID KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK

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

    Other Clearances by Cooper Biomedical, Inc.

    K Number Device Name
    K863868 IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT
    K864512 IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO
    K863301 DEMAND TOTAL PROTEIN
    K861926 WORTHINGTON HDL PRECIPITATING REAGENT SET
    K854130 DEMAND ETHYL ALCOHOL
    K853949 DEMAND ACID PHOSPHATASE REAGENT
    K852262 ASSIST CLINICAL CHEMISTRY ANALYZER
    K851285 RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI
    K851284 RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM
    K851286 RADIAL IMMUNODIFFUSION PLATES C3 & C4
    Search all 19 clearances from Cooper Biomedical, Inc. →