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

    FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

    K Number: K994419 · Decision Jun 28, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    33
    Applicant Total
    2
    Review Days
    182

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    Basic Information

    Device Name
    FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
    K Number
    K994419
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Qualisys Diagnostics, Inc.
    Date Received
    December 29, 1999
    Decision Date
    June 28, 2000
    Product Code
    LTJ
    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
    LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

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    Other Clearances by Qualisys Diagnostics, Inc.

    K Number Device Name
    K990234 QUALISYS PSA IMMUNOASSAY