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

    SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT

    K Number: K051307 · Decision Jun 13, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    89
    Applicant Total
    270
    Review Days
    25

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    Basic Information

    Device Name
    SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
    K Number
    K051307
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3170
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    May 19, 2005
    Decision Date
    June 13, 2005
    Product Code
    JXM
    Advisory Committee
    Clinical Toxicology
    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
    JXM Enzyme Immunoassay, Benzodiazepine

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