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

    GLYCOMARK

    K Number: K031604 · Decision Sep 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    123

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    GLYCOMARK
    K Number
    K031604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7470
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tomen America, Inc.
    Date Received
    May 22, 2003
    Decision Date
    September 22, 2003
    Product Code
    NOZ
    Advisory Committee
    Hematology
    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
    NOZ Assay, 1,5-Anhydroglucitol (15ag)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NOZ), ordered by most recent decision date.

    Diazyme 1,5-AG Assay

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all