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

    ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS

    K Number: K972004 · Decision Jun 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    37
    Applicant Total
    31
    Review Days
    17

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    Basic Information

    Device Name
    ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
    K Number
    K972004
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alko Diagnostic Corp.
    Date Received
    May 30, 1997
    Decision Date
    June 16, 1997
    Product Code
    CGZ
    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
    CGZ Electrode, Ion-Specific, Chloride

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    Other Clearances by Alko Diagnostic Corp.

    K Number Device Name
    K001484 CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838
    K982501 ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44
    K970921 STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)
    K962864 THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS
    K963734 ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
    K960085 ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS
    K955154 CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT
    K951071 ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS
    K950902 ALKO TONOMETERED SALINE CONTROL
    K945966 ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS
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