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

    IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT

    K Number: K964762 · Decision Apr 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    281
    Review Days
    149

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    Basic Information

    Device Name
    IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
    K Number
    K964762
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5210
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Instruments, Inc.
    Date Received
    November 27, 1996
    Decision Date
    April 25, 1997
    Product Code
    DDB
    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
    DDB Ceruloplasmin, Antigen, Antiserum, Control

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    Other Clearances by Beckman Instruments, Inc.

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    K981403 IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
    K981354 ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
    K980173 ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
    K974816 ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
    K974564 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
    K974110 IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
    K974452 VIGIL LIPID CONTROL
    K973932 BECKMAN CALIBRATOR 2 (CAL2)
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