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

    FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT

    K Number: K002638 · Decision Jan 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    146

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    Basic Information

    Device Name
    FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
    K Number
    K002638
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1025
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Future Diagnostics B.V.
    Date Received
    August 24, 2000
    Decision Date
    January 17, 2001
    Product Code
    CKG
    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
    CKG Radioimmunoassay, Acth

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    Other Clearances by Future Diagnostics B.V.

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    K000471 FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT