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

    PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY

    K Number: K964864 · Decision Feb 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    41
    Applicant Total
    5
    Review Days
    62

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    Basic Information

    Device Name
    PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY
    K Number
    K964864
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alexon Biomedical, Inc.
    Date Received
    December 4, 1996
    Decision Date
    February 4, 1997
    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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