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

    SCANNING SYS., AUTO. COMP., ACS1000

    K Number: K772140 · Decision Dec 5, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    34
    Applicant Total
    69
    Review Days
    21

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    Basic Information

    Device Name
    SCANNING SYS., AUTO. COMP., ACS1000
    K Number
    K772140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5260
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Honeywell, Inc.
    Date Received
    November 14, 1977
    Decision Date
    December 5, 1977
    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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