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

    GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY

    K Number: K983399 · Decision Jan 11, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    26
    Applicant Total
    5
    Review Days
    105

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    Basic Information

    Device Name
    GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
    K Number
    K983399
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3220
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genzyme Diagnostics
    Date Received
    September 28, 1998
    Decision Date
    January 11, 1999
    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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    Other Clearances by Genzyme Diagnostics

    K Number Device Name
    K043385 OSOM HCG COMBO TEST
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    K964155 CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST