BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODEL 5500 CEAS

    K Number: K934977 · Decision Jan 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    11
    Applicant Total
    7
    Review Days
    84

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    Basic Information

    Device Name
    MODEL 5500 CEAS
    K Number
    K934977
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1795
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Esa, Inc.
    Date Received
    October 19, 1993
    Decision Date
    January 11, 1994
    Product Code
    CDF
    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
    CDF Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin

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