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

    LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM

    K Number: K953926 · Decision Sep 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    125
    Applicant Total
    7
    Review Days
    31

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    Basic Information

    Device Name
    LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM
    K Number
    K953926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    International Enzymes, Inc.
    Date Received
    August 15, 1995
    Decision Date
    September 15, 1995
    Product Code
    DCK
    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
    DCK C-Reactive Protein, Antigen, Antiserum, And Control

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    Other Clearances by International Enzymes, Inc.

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    K963085 LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III
    K953927 LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM
    K950802 LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM
    K944486 LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E
    K944513 LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E