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

    IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C

    K Number: K865027 · Decision Feb 26, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    15
    Applicant Total
    9
    Review Days
    65

    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
    IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C
    K Number
    K865027
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Cis-Us, Inc.
    Date Received
    December 23, 1986
    Decision Date
    February 26, 1987
    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

    Similar 510(k) Clearances

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

    RadGil2

    FDA 510(k)
    FDA Unclassified ·Unknown

    Raycell MK1

    FDA 510(k)
    FDA Unclassified ·Unknown

    SANGRAY

    FDA 510(k)
    FDA Unclassified ·Unknown

    Raycell Mk2

    FDA 510(k)
    FDA Unclassified ·Unknown

    RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400

    FDA 510(k)
    FDA Unclassified ·Unknown

    RAYCELL X-RAY BLOOD IRRADIATOR

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Cis-Us, Inc.

    K Number Device Name
    K951708 ELSA-HCT
    K950211 ELSA-PTH
    K890799 CURIETRON 192 HIGH DOSE RATE
    K882449 CESIUM 137 SOURCE, MODEL CSM-40
    K871502 PERSONNEL PROTECTIVE SHIELD
    K863778 VENTICIS II
    K860823 ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT
    K860824 TSHK-NN RIA KIT