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

    V-MARC 88A COMPUTER

    K Number: K862089 · Decision Jul 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    38

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    Basic Information

    Device Name
    V-MARC 88A COMPUTER
    K Number
    K862089
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5300
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    V.Marc, A Div. of Pictorial, Inc.
    Date Received
    June 2, 1986
    Decision Date
    July 10, 1986
    Product Code
    KQH
    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
    KQH Red-Cell Indices

    Other Clearances by V.Marc, A Div. of Pictorial, Inc.

    K Number Device Name
    K871853 V-MARC 88A COMPUTER