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

    ACCU-CHEK AVIVA PLUS SYSTEM

    K Number: K133862 · Decision Apr 29, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    6
    Review Days
    131

    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
    ACCU-CHEK AVIVA PLUS SYSTEM
    K Number
    K133862
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Corporation
    Date Received
    December 19, 2013
    Decision Date
    April 29, 2014
    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 Roche Diagnostics Corporation

    K Number Device Name
    K141929 ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
    K142089 ACCU-CHEK AVIVA EXPERT SYSTEM
    K112528 ELECSYS T4 CALCHECK 5
    K070172 AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
    K070174 AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY