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

    21 HEMATOLOGY REAGENTS

    K Number: K853304 · Decision Nov 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    379
    Applicant Total
    15
    Review Days
    99

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    Basic Information

    Device Name
    21 HEMATOLOGY REAGENTS
    K Number
    K853304
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    In Vitro Diagnostics, Inc.
    Date Received
    August 5, 1985
    Decision Date
    November 12, 1985
    Product Code
    GKZ
    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
    GKZ Counter, Differential Cell

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    K873832 REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801
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