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

    LXN FRUCTOSAMINE TEST SYSTEM

    K Number: K962597 · Decision Jun 13, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    248
    Applicant Total
    7
    Review Days
    346

    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
    LXN FRUCTOSAMINE TEST SYSTEM
    K Number
    K962597
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7470
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lxn Corp.
    Date Received
    July 2, 1996
    Decision Date
    June 13, 1997
    Product Code
    LCP
    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
    LCP Assay, Glycosylated Hemoglobin

    Similar 510(k) Clearances

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

    Nova Allegro HbA1c Assay, Nova Allegro Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    Q-Pad Test System

    FDA 510(k)
    FDA Class 2 ·Hematology

    Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    Aina HbA1c Monitoring System 2

    FDA 510(k)
    FDA Class 2 ·Hematology

    PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

    FDA 510(k)
    FDA Class 2 ·Hematology

    OneDraw A1C Test System

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

    Other Clearances by Lxn Corp.

    K Number Device Name
    K002688 PERSONAL GLUCOSE CONTROL CHARTING SYSTEM
    K991754 GO GLUCOSE MONITORING SYSTEM
    K990942 DUET II GLUCOSE CONTROL MONITORING SYSTEM
    K973140 DUET GLUCOSE CONTROL MONITORING SYSTEM
    K960034 LXN BLOOD GLUCOSE TEST SYSTEM
    K955629 LXN FRUCTOSAMINE TEST