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

    BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT

    K Number: K952568 · Decision Aug 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    281
    Review Days
    64

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    Basic Information

    Device Name
    BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT
    K Number
    K952568
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Instruments, Inc.
    Date Received
    June 5, 1995
    Decision Date
    August 8, 1995
    Product Code
    LCR
    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
    LCR Fluorescent Immunoassay, Tobramycin

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