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

    COLORPAC TOXIN A

    K Number: K980185 · Decision Jul 17, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    41
    Applicant Total
    632
    Review Days
    178

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    Basic Information

    Device Name
    COLORPAC TOXIN A
    K Number
    K980185
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    January 20, 1998
    Decision Date
    July 17, 1998
    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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