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

    VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM

    K Number: K923122 · Decision Oct 26, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    49
    Review Days
    122

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    Basic Information

    Device Name
    VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
    K Number
    K923122
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomerieux Vitek, Inc.
    Date Received
    June 26, 1992
    Decision Date
    October 26, 1992
    Product Code
    LFY
    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
    LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster

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    Other Clearances by Biomerieux Vitek, Inc.

    K Number Device Name
    K973819 VIDAS D-DIMER (DD) ASSAY
    K972895 VIDAS ROTAVIRUS (RTV) ASSAY
    K965092 VIDAS ROTAVIRUS ASSAY
    K964887 VIDAS C. DIFFICILE TOXIN A II ASSAY
    K955627 VIDAS CHLAMYDIA BLOCKING ASSAY
    K962549 VIDAS CREATINE KINASE MB ASSAY 30-421
    K962609 GRAM NEGATIVE IDENTIFICATION PLUS CARD
    K952095 VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
    K955647 VIDAS ESTRADIOL II (E2II) ASSAY
    K943812 VIDAS LYME SCREEN II
    Search all 49 clearances from Biomerieux Vitek, Inc. →