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

    STANBIO PROSTATIC ACID PHOSPHATASE TEST

    K Number: K800693 · Decision Apr 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    47
    Review Days
    20

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    Basic Information

    Device Name
    STANBIO PROSTATIC ACID PHOSPHATASE TEST
    K Number
    K800693
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Stanbio Laboratory
    Date Received
    March 27, 1980
    Decision Date
    April 16, 1980
    Product Code
    CKE
    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
    CKE Acid Phosphatase, Thymolphthale Inmonophosphate

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