BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    FRESHFROZEN CELLS, HEP-2

    K Number: K962782 · Decision Aug 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    169
    Applicant Total
    37
    Review Days
    43

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    Basic Information

    Device Name
    FRESHFROZEN CELLS, HEP-2
    K Number
    K962782
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2280
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostic Hybrids, Inc.
    Date Received
    July 17, 1996
    Decision Date
    August 29, 1996
    Product Code
    KIR
    Advisory Committee
    Hematology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KIR Cells, Animal And Human, Cultured

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