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

    ABX MICROS 60 HEMATOLOGY ANALYZER

    K Number: K014203 · Decision Feb 28, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    10
    Review Days
    69

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    Basic Information

    Device Name
    ABX MICROS 60 HEMATOLOGY ANALYZER
    K Number
    K014203
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abx Diagnostics
    Date Received
    December 21, 2001
    Decision Date
    February 28, 2002
    Product Code
    GKX
    Advisory Committee
    Hematology
    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
    GKX Instrument, Automated Platelet Counting

    Similar 510(k) Clearances

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

    CLEAR POROUS PLASTIC-HYPOALLERGENIC

    FDA 510(k)
    FDA Class 2 ·Hematology
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    Other Clearances by Abx Diagnostics

    K Number Device Name
    K030799 MICROS 60
    K030144 MODIFICATION TO PENTRA 60 AND PENTRA 60C+
    K024002 PENTRA 80
    K022200 PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
    K003677 ABX PENTRA 60C+ HEMATOLOGY ANALYZER
    K002646 ABX MICROS CRP
    K992511 ABX PENTRA 60 HEMATOLOGY ANALYZER
    K991839 ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER
    K990311 VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER