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

    FACTPLUS ONE STEP PREGNANCY TEST

    K Number: K962521 · Decision Jul 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    2
    Review Days
    40

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    Basic Information

    Device Name
    FACTPLUS ONE STEP PREGNANCY TEST
    K Number
    K962521
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Direct Access Diagnostics
    Date Received
    June 19, 1996
    Decision Date
    July 29, 1996
    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 Direct Access Diagnostics

    K Number Device Name
    K964108 FACT PLUS PREGNANCY TEST