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

    PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI

    K Number: K893508 · Decision Aug 4, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    44
    Applicant Total
    505
    Review Days
    91

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    Basic Information

    Device Name
    PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
    K Number
    K893508
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    May 5, 1989
    Decision Date
    August 4, 1989
    Product Code
    JFH
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JFH Acid Phosphatase (Prostatic), Tartrate Inhibited

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