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

    SYSMEX SF-3000

    K Number: K950508 · Decision Nov 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    18
    Review Days
    270

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    Basic Information

    Device Name
    SYSMEX SF-3000
    K Number
    K950508
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sysmex Corp.
    Date Received
    February 6, 1995
    Decision Date
    November 3, 1995
    Product Code
    FPK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FPK Tubing, Fluid Delivery

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    Other Clearances by Sysmex Corp.

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    K981761 SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
    K971736 SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER
    K964946 SYSMEX CA-1000/SYSMEX CA-5000
    K964375 SYSMEX SE/RAM-1
    K961054 SYSMEX UF-100
    K945837 SYSMEX(TM) F-820, 520
    K942097 TOA MEDICAL ELECTRONICS CA-5000
    Search all 18 clearances from Sysmex Corp. →