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

    PREGNANCY TEST KIT, OVER-THE-COUNTER

    K Number: K780321 · Decision Apr 4, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    6
    Review Days
    39

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    Basic Information

    Device Name
    PREGNANCY TEST KIT, OVER-THE-COUNTER
    K Number
    K780321
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Intl. Diagnostic, Inc.
    Date Received
    February 24, 1978
    Decision Date
    April 4, 1978
    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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    K802343 PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO