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

    ACP KINETIC TEST (ACID PHOSPHATASE TEST)

    K Number: K881204 · Decision Apr 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    82
    Review Days
    38

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    Basic Information

    Device Name
    ACP KINETIC TEST (ACID PHOSPHATASE TEST)
    K Number
    K881204
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sclavo, Inc.
    Date Received
    March 21, 1988
    Decision Date
    April 28, 1988
    Product Code
    CKB
    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
    CKB Acid Phosphatase, Naphthyl Phosphate

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