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

    FACT PLUS PREGNANCY TEST

    K Number: K964108 · Decision Nov 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    223
    Applicant Total
    2
    Review Days
    34

    Basic Information

    Device Name
    FACT PLUS PREGNANCY TEST
    K Number
    K964108
    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
    October 15, 1996
    Decision Date
    November 18, 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
    K962521 FACTPLUS ONE STEP PREGNANCY TEST