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

    A-1 IN-HOME PREGNANCY TEST

    K Number: K813272 · Decision Dec 17, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    3
    Review Days
    27

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    Basic Information

    Device Name
    A-1 IN-HOME PREGNANCY TEST
    K Number
    K813272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    C.F. Medical, Inc.
    Date Received
    November 20, 1981
    Decision Date
    December 17, 1981
    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 C.F. Medical, Inc.

    K Number Device Name
    K812788 A-1 TEST
    K812789 ACU-SLIDE TEST