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

    PROSTATE SPECIFIC ANTIGEN METHOD

    K Number: K973101 · Decision Sep 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    33
    Applicant Total
    13
    Review Days
    30

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    Basic Information

    Device Name
    PROSTATE SPECIFIC ANTIGEN METHOD
    K Number
    K973101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dade Chemistry Systems, Inc.
    Date Received
    August 19, 1997
    Decision Date
    September 18, 1997
    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 Dade Chemistry Systems, Inc.

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    K971141 FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
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