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

    UNIMARK HCG COMBO PREGNANCY TEST

    K Number: K013194 · Decision Oct 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    4
    Review Days
    15

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    Basic Information

    Device Name
    UNIMARK HCG COMBO PREGNANCY TEST
    K Number
    K013194
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotech Atlantic, Inc.
    Date Received
    September 25, 2001
    Decision Date
    October 10, 2001
    Product Code
    JHI
    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
    JHI Visual, Pregnancy Hcg, Prescription Use

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    Other Clearances by Biotech Atlantic, Inc.

    K Number Device Name
    K032992 UNIMARK HOME PREGNANCY TEST DEVICE
    K960174 UNIMARK MIDSTREAM PREGNANCY TEST STICK
    K941090 UNISTEP HCG PREGNANCY TEST STRIP