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

    VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY

    K Number: K920952 · Decision Apr 7, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    86
    Applicant Total
    39
    Review Days
    41

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    Basic Information

    Device Name
    VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY
    K Number
    K920952
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitek Systems, Inc.
    Date Received
    February 26, 1992
    Decision Date
    April 7, 1992
    Product Code
    DBF
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DBF Ferritin, Antigen, Antiserum, Control

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    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
    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
    K911429 VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED
    Search all 39 clearances from Vitek Systems, Inc. →