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

    DU PONT TOBRAMYCIN ASSAY REAGENTS

    K Number: K850058 · Decision Jan 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    253
    Review Days
    10

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    Basic Information

    Device Name
    DU PONT TOBRAMYCIN ASSAY REAGENTS
    K Number
    K850058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    January 8, 1985
    Decision Date
    January 18, 1985
    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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    K951441 DUPONT ACA DIGOXIN (DGN A) METHOD
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    Search all 253 clearances from E.I. Dupont DE Nemours & Co., Inc. →