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

    VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD

    K Number: K925916 · Decision Mar 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    49
    Review Days
    120

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    Basic Information

    Device Name
    VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD
    K Number
    K925916
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomerieux Vitek, Inc.
    Date Received
    November 23, 1992
    Decision Date
    March 23, 1993
    Product Code
    LQL
    Advisory Committee
    Microbiology
    Review Advisory Committee
    CH
    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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