BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Assure Titanium Blood Glucose Monitoring System

    K Number: K200788 · Decision May 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    13
    Applicant Total
    18
    Review Days
    788

    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
    Assure Titanium Blood Glucose Monitoring System
    K Number
    K200788
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arkray, Inc.
    Date Received
    March 26, 2020
    Decision Date
    May 23, 2022
    Product Code
    PZI
    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
    PZI Prescription Use Blood Glucose Meter For Near-Patient Testing

    Similar 510(k) Clearances

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

    cobas pulse blood glucose monitoring system

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    XPER Technology PREMIUM Pro Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    cobas pulse blood glucose monitoring system

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    StatStrip Glucose Hospital Meter System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    StatStrip Xpress 2 Glucose Hospital Meter System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    StatStrip Xpress Glucose Hospital Meter System

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

    Other Clearances by Arkray, Inc.

    K Number Device Name
    K232416 AUTION EYE AI-4510 Urine Particle Analysis System
    K193514 AUTION MAX AX-4060 Urinalysis System
    K221175 Multi-Lancet Device 2, ReliOn Premier Lancing Device
    K160062 AUTION ELEVEN Semi-Automated Urinalysis System
    K121456 AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL
    K093098 AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM
    K053401 SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
    K051648 SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS
    K051432 SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS
    K050790 SPOTCHEM II LDH TEST
    Search all 18 clearances from Arkray, Inc. →