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

    FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT

    K Number: K000471 · Decision Apr 11, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    85
    Applicant Total
    2
    Review Days
    57

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    Basic Information

    Device Name
    FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
    K Number
    K000471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1545
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Future Diagnostics B.V.
    Date Received
    February 14, 2000
    Decision Date
    April 11, 2000
    Product Code
    CEW
    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
    CEW Radioimmunoassay, Parathyroid Hormone

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    Other Clearances by Future Diagnostics B.V.

    K Number Device Name
    K002638 FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT