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

    C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100

    K Number: K981871 · Decision Nov 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    125
    Applicant Total
    94
    Review Days
    165

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    Basic Information

    Device Name
    C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
    K Number
    K981871
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostic Systems Laboratories, Inc.
    Date Received
    May 28, 1998
    Decision Date
    November 9, 1998
    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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