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

    PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT

    K Number: K964756 · Decision Apr 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    147

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    Basic Information

    Device Name
    PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
    K Number
    K964756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wano-Tech Corp.
    Date Received
    November 27, 1996
    Decision Date
    April 23, 1997
    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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