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

    GC II AGAR WITH ISOVITALEX

    K Number: K932882 · Decision Sep 24, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    33
    Review Days
    102

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    Basic Information

    Device Name
    GC II AGAR WITH ISOVITALEX
    K Number
    K932882
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton Dickinson Microbiology Systems
    Date Received
    June 14, 1993
    Decision Date
    September 24, 1993
    Product Code
    JSO
    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
    JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

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