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

    ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM

    K Number: K090057 · Decision Apr 8, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    6
    Review Days
    90

    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
    ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
    K Number
    K090057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acon Laboratories Co.
    Date Received
    January 8, 2009
    Decision Date
    April 8, 2009
    Product Code
    NBW
    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
    NBW System, Test, Blood Glucose, Over The Counter

    Similar 510(k) Clearances

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

    On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TeleRPM Gen2 Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RIGHTEST Blood Glucose Monitoring System Max Tel

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Acon Laboratories Co.

    K Number Device Name
    K061559 ACON URINALYSIS REAGENT STRIPS
    K023766 ACON STREP A TWIST TEST DEVICE
    K020313 ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
    K010582 ACON STREP A RAPID TEST STRIP
    K980736 ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST