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

    UNIMARK MIDSTREAM PREGNANCY TEST STICK

    K Number: K960174 · Decision Apr 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    4
    Review Days
    76

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    Basic Information

    Device Name
    UNIMARK MIDSTREAM PREGNANCY TEST STICK
    K Number
    K960174
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotech Atlantic, Inc.
    Date Received
    January 16, 1996
    Decision Date
    April 1, 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 Biotech Atlantic, Inc.

    K Number Device Name
    K032992 UNIMARK HOME PREGNANCY TEST DEVICE
    K013194 UNIMARK HCG COMBO PREGNANCY TEST
    K941090 UNISTEP HCG PREGNANCY TEST STRIP