BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    RESUBMITTED MODIFIED RUBALEX

    K Number: K901637 · Decision Apr 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    21
    Review Days
    17

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    Basic Information

    Device Name
    RESUBMITTED MODIFIED RUBALEX
    K Number
    K901637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Orion Corp.
    Date Received
    April 9, 1990
    Decision Date
    April 26, 1990
    Product Code
    LQN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LQN Latex Agglutination Assay, Rubella

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