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

    UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE

    K Number: K981573 · Decision Sep 15, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    44
    Applicant Total
    22
    Review Days
    134

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    Basic Information

    Device Name
    UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE
    K Number
    K981573
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    United Biotech, Inc.
    Date Received
    May 4, 1998
    Decision Date
    September 15, 1998
    Product Code
    JFH
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    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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