BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACTIM PROM AND CONTROLS

    K Number: K061886 · Decision Jan 25, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    206

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ACTIM PROM AND CONTROLS
    K Number
    K061886
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1550
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medix Biochemica
    Date Received
    July 3, 2006
    Decision Date
    January 25, 2007
    Product Code
    OAM
    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
    OAM Immunoassay, Insulin-Like Growth Factor Binding Protein-1

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OAM), ordered by most recent decision date.

    ACTIM PROM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all