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

    ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN

    K Number: K964670 · Decision Feb 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    9
    Applicant Total
    296
    Review Days
    75

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    Basic Information

    Device Name
    ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
    K Number
    K964670
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    November 21, 1996
    Decision Date
    February 4, 1997
    Product Code
    LFW
    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
    LFW Fluorescence Polarization Immunoassay, Tobramycin

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