BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    EVATEST STRIP

    K Number: K936013 · Decision Feb 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    3
    Review Days
    71

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    Basic Information

    Device Name
    EVATEST STRIP
    K Number
    K936013
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boehringer Mannheim Italia Spa
    Date Received
    December 16, 1993
    Decision Date
    February 25, 1994
    Product Code
    LCX
    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
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

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    Other Clearances by Boehringer Mannheim Italia Spa

    K Number Device Name
    K955266 ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT
    K935502 EVENT TEST STRIP HCG