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

    UC IMU A

    K Number: K904125 · Decision Sep 24, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    4
    Review Days
    18

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    Basic Information

    Device Name
    UC IMU A
    K Number
    K904125
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5580
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Eucardio Laboratory, Inc.
    Date Received
    September 6, 1990
    Decision Date
    September 24, 1990
    Product Code
    DER
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control

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    Other Clearances by Eucardio Laboratory, Inc.

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    K942464 UC QIK 1-STEP HCG TEST
    K926500 UC QIK PREGNANCY TEST
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