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

    ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW

    K Number: K820401 · Decision Mar 15, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    191
    Applicant Total
    1
    Review Days
    31

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    Basic Information

    Device Name
    ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW
    K Number
    K820401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Orhto Diagnostic Systems, Inc.
    Date Received
    February 12, 1982
    Decision Date
    March 15, 1982
    Product Code
    JPK
    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
    JPK Mixture, Hematology Quality Control

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