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

    PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR

    K Number: K973100 · Decision Sep 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    244
    Applicant Total
    13
    Review Days
    41

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    Basic Information

    Device Name
    PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR
    K Number
    K973100
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dade Chemistry Systems, Inc.
    Date Received
    August 19, 1997
    Decision Date
    September 29, 1997
    Product Code
    JIT
    Advisory Committee
    Clinical Chemistry
    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
    JIT Calibrator, Secondary

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