BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM

    K Number: K102316 · Decision Oct 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    400
    Applicant Total
    2
    Review Days
    417

    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
    GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
    K Number
    K102316
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Broadmaster Biotech Corporation
    Date Received
    August 16, 2010
    Decision Date
    October 7, 2011
    Product Code
    CGA
    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
    CGA Glucose Oxidase, Glucose

    Similar 510(k) Clearances

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

    ABL90 FLEX PLUS System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    YSI 2900C Biochemistry Analyzer

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EasyStat 300

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Cholestech LDX ™ System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    i-STAT G cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    i-STAT CG8+ cartridge with the i-STAT 1 System

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

    Other Clearances by Broadmaster Biotech Corporation

    K Number Device Name
    K130621 BROADMASTER HEALTHCARE SYSTEM