BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    VISUWELL REAGIN II

    K Number: K952802 · Decision May 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    339

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    Basic Information

    Device Name
    VISUWELL REAGIN II
    K Number
    K952802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3820
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomira Diagnostics, Inc.
    Date Received
    June 19, 1995
    Decision Date
    May 23, 1996
    Product Code
    GMQ
    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
    GMQ Antigens, Nontreponemal, All

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    Other Clearances by Biomira Diagnostics, Inc.

    K Number Device Name
    K932453 VISUWELL SYPHILIS ANTIBODY