BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    EPOC CHLORIDE TEST AND EPOC CREATININE TEST

    K Number: K113726 · Decision Oct 5, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    6
    Applicant Total
    7
    Review Days
    291

    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
    EPOC CHLORIDE TEST AND EPOC CREATININE TEST
    K Number
    K113726
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epocal, Inc.
    Date Received
    December 19, 2011
    Decision Date
    October 5, 2012
    Product Code
    CGL
    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
    CGL Electrode, Ion Based, Enzymatic, Creatinine

    Similar 510(k) Clearances

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

    Nova StatSensor Creatinine Hospital Meter System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ABL8X7 FLEX

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STAT PROFILE M7 ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    I-STAT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RENALYZER PRX 90

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

    Other Clearances by Epocal, Inc.

    K Number Device Name
    K200107 epoc Blood Analysis System
    K171247 epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
    K093297 EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
    K092849 BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
    K090109 BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
    K061597 EPOC BLOOD ANALYSIS SYSTEM