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

    CELLABS GIARDIA CEL I.F. TEST

    K Number: K912152 · Decision Aug 12, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    89

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    Basic Information

    Device Name
    CELLABS GIARDIA CEL I.F. TEST
    K Number
    K912152
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3220
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Celltech Diagnostics , Ltd.
    Date Received
    May 15, 1991
    Decision Date
    August 12, 1991
    Product Code
    MHI
    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
    MHI Giardia Spp.

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