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

    CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY

    K Number: K951059 · Decision Jun 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    30
    Applicant Total
    125
    Review Days
    104

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    Basic Information

    Device Name
    CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY
    K Number
    K951059
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3950
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ciba Corning Diagnostics Corp.
    Date Received
    March 7, 1995
    Decision Date
    June 19, 1995
    Product Code
    LEH
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LEH Radioimmunoassay, Vancomycin

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    Other Clearances by Ciba Corning Diagnostics Corp.

    K Number Device Name
    K962559 ACS CORTISOL IMMUNOASSAY
    K963251 CIBA CORNING ACS;180 DPD ASSAY
    K961807 CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
    K961657 CIBA CORNING 400 SYSTEM
    K962021 CIBA CORNING 348 SYSTEM
    K962126 ACS CKMB II IMMUNOASSAY
    K962041 ACS LH2 IMMUNOASSAY
    K961510 ACS FRT4 IMMUNOASSAY
    K960246 LIQUID CARDIAC MARKER 1,2,3 ASSAYED
    K955873 ACS PHENYTOIN ASSAY
    Search all 125 clearances from Ciba Corning Diagnostics Corp. →