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

    ACTIM PROM

    K Number: K123986 · Decision Jan 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    1
    Applicant Total
    17
    Review Days
    379

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    Basic Information

    Device Name
    ACTIM PROM
    K Number
    K123986
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1550
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alere Scarborough, Inc.
    Date Received
    December 26, 2012
    Decision Date
    January 9, 2014
    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 AND CONTROLS

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

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