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

    RIANEN GENTAMICIN RIA KIT

    K Number: K772425 · Decision Jan 5, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    18
    Applicant Total
    18
    Review Days
    7

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    Basic Information

    Device Name
    RIANEN GENTAMICIN RIA KIT
    K Number
    K772425
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    New England Nuclear
    Date Received
    December 29, 1977
    Decision Date
    January 5, 1978
    Product Code
    DJB
    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
    DJB Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.

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    Other Clearances by New England Nuclear

    K Number Device Name
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    K833376 RIANEN LUTEINIZING HORMONE RIA KIT
    K831345 RIANEN PROLACTIN 125I KIT
    K801245 ATOMLIGHT (LIQUID SCINTILLATION SOLUTION
    K792175 RIANEN, VITAMIN B12 ASSAY SYSTEM
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