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

    PROGASTRO CD ASSAY

    K Number: K090239 · Decision Apr 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    41
    Applicant Total
    6
    Review Days
    73

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    Basic Information

    Device Name
    PROGASTRO CD ASSAY
    K Number
    K090239
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prodesse, Inc.
    Date Received
    February 2, 2009
    Decision Date
    April 16, 2009
    Product Code
    LLH
    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
    LLH Reagents, Clostridium Difficile Toxin

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    Other Clearances by Prodesse, Inc.

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