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

    TRACCELL 2000 SLIDE MAPPING SYSTEM

    K Number: K982786 · Decision Oct 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    34
    Applicant Total
    12
    Review Days
    67

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    Basic Information

    Device Name
    TRACCELL 2000 SLIDE MAPPING SYSTEM
    K Number
    K982786
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5260
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Accumed Intl., Inc.
    Date Received
    August 10, 1998
    Decision Date
    October 16, 1998
    Product Code
    JOY
    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
    JOY Device, Automated Cell-Locating

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    Other Clearances by Accumed Intl., Inc.

    K Number Device Name
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    K983309 SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
    K983301 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN
    K972576 GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90
    K964689 TRACCELL 2000 SLIDE MAPPING SYSTEM
    K972756 MODIFICATION OF EST CULTURE SYSTEM II - MYCO
    K965190 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE
    K960366 SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
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