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

    IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C

    K Number: K851828 · Decision Sep 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    15
    Applicant Total
    31
    Review Days
    146

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    Basic Information

    Device Name
    IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C
    K Number
    K851828
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Syncor Intl. Corp.
    Date Received
    April 26, 1985
    Decision Date
    September 19, 1985
    Product Code
    MOT
    Advisory Committee
    Unknown
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MOT Irradiator, Blood To Prevent Graft Versus Host Disease

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    Other Clearances by Syncor Intl. Corp.

    K Number Device Name
    K945825 SECURE SAFETY INSERT
    K850433 CESIUM 137 ENDOMETRIAL SOURCE
    K852023 CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41
    K852665 SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY
    K851033 SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT
    K844735 PTH-RIA
    K850163 IRIDIUM 192 WIRES
    K850208 FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS
    K850726 WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD
    K850434 CS137 SEALED SOURCES
    Search all 31 clearances from Syncor Intl. Corp. →