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

    FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER

    K Number: K122907 · Decision Mar 14, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    5
    Review Days
    174

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    Basic Information

    Device Name
    FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
    K Number
    K122907
    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
    September 21, 2012
    Decision Date
    March 14, 2013
    Product Code
    LCX
    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
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

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    Other Clearances by Polymed Therapeutics, Inc.

    K Number Device Name
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    K132834 FASTEP S10 HCG SERUM/URINE COMBO TEST
    K121065 POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
    K112101 FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS