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

    PHEM-ALERT

    K Number: K032161 · Decision Sep 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    77

    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
    PHEM-ALERT
    K Number
    K032161
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1550
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Femtek,Llc.
    Date Received
    July 15, 2003
    Decision Date
    September 30, 2003
    Product Code
    LNW
    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
    LNW Paper, Obstetric Ph

    Similar 510(k) Clearances

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

    PHEM-ALERT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PHEM-CHEK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OB-PH - PH TEST PAPER

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

    Other Clearances by Femtek,Llc.

    K Number Device Name
    K012230 PHEM-ALERT