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

    UC QIK PREGNANCY TEST

    K Number: K926500 · Decision Jun 7, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    4
    Review Days
    160

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    Basic Information

    Device Name
    UC QIK PREGNANCY TEST
    K Number
    K926500
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eucardio Laboratory, Inc.
    Date Received
    December 29, 1992
    Decision Date
    June 7, 1993
    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 Eucardio Laboratory, Inc.

    K Number Device Name
    K942464 UC QIK 1-STEP HCG TEST
    K904137 UC IMU B
    K904125 UC IMU A