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

    FASTEP S10 HCG SERUM/URINE COMBO TEST

    K Number: K132834 · Decision Jan 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    5
    Review Days
    121

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    Basic Information

    Device Name
    FASTEP S10 HCG SERUM/URINE COMBO TEST
    K Number
    K132834
    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 10, 2013
    Decision Date
    January 9, 2014
    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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    Other Clearances by Polymed Therapeutics, Inc.

    K Number Device Name
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    K121065 POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
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