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

    RAPID GRAM-POSITIVE ID SYSTEM

    K Number: K961730 · Decision Feb 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    33
    Review Days
    277

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    Basic Information

    Device Name
    RAPID GRAM-POSITIVE ID SYSTEM
    K Number
    K961730
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Becton Dickinson Microbiology Systems
    Date Received
    May 3, 1996
    Decision Date
    February 4, 1997
    Product Code
    LQL
    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
    LQL Gram Positive Identification Panel

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