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

    BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER

    K Number: K092849 · Decision Mar 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    88
    Applicant Total
    7
    Review Days
    195

    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
    BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
    K Number
    K092849
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1600
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epocal, Inc.
    Date Received
    September 16, 2009
    Decision Date
    March 30, 2010
    Product Code
    CEM
    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
    CEM Electrode, Ion Specific, Potassium

    Similar 510(k) Clearances

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

    ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ABL90 FLEX PLUS System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EasyStat 300

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ISE Electrodes

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FLEXLAB 3.6, ACCELERATOR A3600

    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
    K113726 EPOC CHLORIDE TEST AND EPOC CREATININE TEST
    K093297 EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
    K090109 BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
    K061597 EPOC BLOOD ANALYSIS SYSTEM