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

    OSTEOMARK NTX POC

    K Number: K992997 · Decision Nov 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    20
    Applicant Total
    11
    Review Days
    63

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    Basic Information

    Device Name
    OSTEOMARK NTX POC
    K Number
    K992997
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1400
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Metrika, Inc.
    Date Received
    September 7, 1999
    Decision Date
    November 9, 1999
    Product Code
    JMM
    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
    JMM Column Chromatography & Color Development, Hydroxyproline

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