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

    PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION

    K Number: K922010 · Decision Jun 19, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    26
    Applicant Total
    10
    Review Days
    50

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    Basic Information

    Device Name
    PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION
    K Number
    K922010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3220
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alexon, Inc.
    Date Received
    April 30, 1992
    Decision Date
    June 19, 1992
    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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    K930451 PROSPEC T GIARDIA MICROTITER ASSAY
    K922675 PROSPECT GIARDIA CONTROLS
    K920817 MODIFICATION PROSPECT GIARDIA RAPID ASSAY
    K912242 PROSPECT(TM/CRYPTOSPORIDIUM
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