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

    GAP-IGG

    K Number: K900343 · Decision Aug 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    90
    Applicant Total
    10
    Review Days
    576

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    Basic Information

    Device Name
    GAP-IGG
    K Number
    K900343
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3110
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Biomerica, Inc.
    Date Received
    January 23, 1990
    Decision Date
    August 22, 1991
    Product Code
    LYR
    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
    LYR Helicobacter Pylori

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