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

    FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS

    K Number: K112101 · Decision Jul 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    110
    Registration Numbers
    110
    Same Product Code
    374
    Applicant Total
    5
    Review Days
    361

    Basic Information

    Device Name
    FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
    K Number
    K112101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    POLYMED THERAPEUTICS, INC
    Date Received
    July 22, 2011
    Decision Date
    July 17, 2012
    Product Code
    JHI
    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
    JHI Visual, Pregnancy Hcg, Prescription Use

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