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

    CIBA CORNING ACS FOLATE ASSAY

    K Number: K943297 · Decision Dec 12, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    63
    Applicant Total
    125
    Review Days
    157

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    Basic Information

    Device Name
    CIBA CORNING ACS FOLATE ASSAY
    K Number
    K943297
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1295
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ciba Corning Diagnostics Corp.
    Date Received
    July 8, 1994
    Decision Date
    December 12, 1994
    Product Code
    CGN
    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
    CGN Acid, Folic, Radioimmunoassay

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