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

    MTM BIOSCANNER K TEST STRIPS

    K Number: K981865 · Decision Feb 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    27
    Review Days
    274

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    Basic Information

    Device Name
    MTM BIOSCANNER K TEST STRIPS
    K Number
    K981865
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1380
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Polymer Technology Systems, Inc.
    Date Received
    May 28, 1998
    Decision Date
    February 26, 1999
    Product Code
    JMK
    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
    JMK Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase

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