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

    BBL MGIT PRODUCTS

    K Number: K954932 · Decision Aug 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    67
    Applicant Total
    13
    Review Days
    299

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    Basic Information

    Device Name
    BBL MGIT PRODUCTS
    K Number
    K954932
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2560
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton Dickinson Diagnostic Instrument Systems
    Date Received
    October 27, 1995
    Decision Date
    August 21, 1996
    Product Code
    MDB
    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
    MDB System, Blood Culturing

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    Other Clearances by Becton Dickinson Diagnostic Instrument Systems

    K Number Device Name
    K954923 BACTEC FUNGAL MEDIUM
    K962210 BACTEC 9050 SYSTEM
    K946268 BACTEC(R) 9000TB SYSTEM
    K960827 QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)
    K954930 BACTEC CULTURE VIALS, LYTIC, ANAEROBIC
    K954921 BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS
    K954925 BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS
    K954927 BACTEC PEDS PLUS/F CULTURE VIALS
    K954924 BACTEC PEDS PLUS CLUTURE VIALS
    K955504 QBC ACCUREAD SYSTEM
    Search all 13 clearances from Becton Dickinson Diagnostic Instrument Systems →