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

    EVENT TEST STRIP HCG

    K Number: K935502 · Decision Jan 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    3
    Review Days
    72

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    Basic Information

    Device Name
    EVENT TEST STRIP HCG
    K Number
    K935502
    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
    November 16, 1993
    Decision Date
    January 27, 1994
    Product Code
    JHI
    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
    JHI Visual, Pregnancy Hcg, Prescription Use

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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
    K936013 EVATEST STRIP