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

    E. COLI 0157 LATEX TEST

    K Number: K903714 · Decision Jan 24, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    27
    Review Days
    163

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    Basic Information

    Device Name
    E. COLI 0157 LATEX TEST
    K Number
    K903714
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3255
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Pro-Lab, Inc.
    Date Received
    August 14, 1990
    Decision Date
    January 24, 1991
    Product Code
    GNA
    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
    GNA Antisera, All Types, Escherichia Coli

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