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

    BACTICARD CANDIDA

    K Number: K935124 · Decision Feb 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    15
    Applicant Total
    137
    Review Days
    120

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    Basic Information

    Device Name
    BACTICARD CANDIDA
    K Number
    K935124
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Remel Co.
    Date Received
    October 28, 1993
    Decision Date
    February 25, 1994
    Product Code
    JXB
    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
    JXB Kit, Identification, Yeast

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