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

    VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED

    K Number: K911429 · Decision Jun 24, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    6
    Applicant Total
    39
    Review Days
    90

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED
    K Number
    K911429
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Vitek Systems, Inc.
    Date Received
    March 26, 1991
    Decision Date
    June 24, 1991
    Product Code
    LQM
    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
    LQM Gram Negative Identification Panel

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LQM), ordered by most recent decision date.

    ROCHE OXI/FERM II

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VITEK RAPID CALL-GRAM NEGATIV IDENT CARD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SCEPTOR IDENTIFICATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SENSITITRE AUTO ID PLATE AP80

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Vitek Systems, Inc.

    K Number Device Name
    K920661 VIDAS CMV IGG ASSAY
    K921302 VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
    K921176 VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
    K920952 VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY
    K915884 VIDAS CHLAMYDIA ASSAY, MODIFICATION
    K905211 VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
    K912371 BIOMERIEUX RSV DIRECT IF KIT
    K910230 LYME-SPOT IF KIT
    K910210 SLIDEX MENINGITE-KIT 5
    K910304 RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA
    Search all 39 clearances from Vitek Systems, Inc. →