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

    KANAMYCIN RIA

    K Number: K772038 · Decision Jan 12, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    6
    Review Days
    76

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    Basic Information

    Device Name
    KANAMYCIN RIA
    K Number
    K772038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3520
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Monitor Science Corp.
    Date Received
    October 28, 1977
    Decision Date
    January 12, 1978
    Product Code
    KJI
    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
    KJI Radioimmunoassay, Kanamycin

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    Other Clearances by Monitor Science Corp.

    K Number Device Name
    K790580 RIA KIT, PROSTATIC ACID
    K780949 BIO-MONITOR AMIKACIN
    K780950 BIO-MONITOR TOBRAMYCIN
    K780951 BIO-MONITOR GENTAMICIN
    K772039 BETA-HCG RIA