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

    TOBRAMYCIN REAGENT

    K Number: K832763 · Decision Mar 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    10
    Review Days
    220

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    Basic Information

    Device Name
    TOBRAMYCIN REAGENT
    K Number
    K832763
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Biosan Laboratories, Inc.
    Date Received
    August 16, 1983
    Decision Date
    March 23, 1984
    Product Code
    KLB
    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
    KLB Radioimmunoassay, Tobramycin

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    Other Clearances by Biosan Laboratories, Inc.

    K Number Device Name
    K860642 PHOTRON VISUAL FIELD ANALYZER
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    K833193 RADIOIMMUNOASSAY, THYROID STIMU. HORMONE
    K834023 BIO-SCIENCE LABORATORIES T4 REAGENT
    K833318 NORMAL GOAT SERUM
    K833192 NORMAL URINE CONTROL
    K833191 ABNORMAL URINE CONTROL
    K833320 AMBERLITE CG50 RESIN, 100-200 MESH
    K833319 BIO-REX 70 RESIN 100-200 MESH PH6.2