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

    TOBRAMYCIN RIA KIT

    K Number: K760967 · Decision Dec 22, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    321
    Review Days
    48

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    Basic Information

    Device Name
    TOBRAMYCIN RIA KIT
    K Number
    K760967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Products Corp.
    Date Received
    November 4, 1976
    Decision Date
    December 22, 1976
    Product Code
    KLB
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KLB Radioimmunoassay, Tobramycin

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    K022603 IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
    K022118 IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
    K021257 ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
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