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

    E. HISTOLYTICA TEST

    K Number: K955895 · Decision Aug 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    36
    Review Days
    248

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    Basic Information

    Device Name
    E. HISTOLYTICA TEST
    K Number
    K955895
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3220
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Techlab, Inc.
    Date Received
    December 26, 1995
    Decision Date
    August 30, 1996
    Product Code
    KHW
    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
    KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

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