BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE

    K Number: K093297 · Decision Jun 9, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    26
    Applicant Total
    7
    Review Days
    231

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    Basic Information

    Device Name
    EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
    K Number
    K093297
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1450
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epocal, Inc.
    Date Received
    October 21, 2009
    Decision Date
    June 9, 2010
    Product Code
    KHP
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KHP Acid, Lactic, Enzymatic Method

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