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

    KIT, RIA, GENTAMICIN SULF.

    K Number: K760068 · Decision Jul 20, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    18
    Applicant Total
    18
    Review Days
    34

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    KIT, RIA, GENTAMICIN SULF.
    K Number
    K760068
    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
    June 16, 1976
    Decision Date
    July 20, 1976
    Product Code
    DJB
    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
    DJB Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DJB), ordered by most recent decision date.

    AMES TDA SISOMICIN TEST-CONTROL SERUM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GENTAMICIN TEST PACK-ACA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AMES TDA GENTAMICIN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MRI GENTAMICIN RIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COAT-A-COUNT GENTAMICIN RIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GAMMA STICK GENTAMICIN RIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

    Other Clearances by New England Nuclear

    K Number Device Name
    K841478 RIANEN CYCLIC-AMP RADIOIMMUNOASSAY
    K840301 RIANEN ESTRIOL RADIOIMMUNOASSAY KIT
    K834038 RIANEN FOLLICLE STIMULATING HORMONE
    K833376 RIANEN LUTEINIZING HORMONE RIA KIT
    K831345 RIANEN PROLACTIN 125I KIT
    K801245 ATOMLIGHT (LIQUID SCINTILLATION SOLUTION
    K792175 RIANEN, VITAMIN B12 ASSAY SYSTEM
    K790817 RIA KIT, QUANTITATION OF PROSTATIC ACID
    K782110 RIA KIT, RIANEN CORTISOL
    K781888 ASSAY SYSTEM, FERRITIN I KIT
    Search all 18 clearances from New England Nuclear →