BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BLOOD GAS/ISE LINEARITY CONTROL

    K Number: K920285 · Decision Jul 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    66
    Applicant Total
    21
    Review Days
    174

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    Basic Information

    Device Name
    BLOOD GAS/ISE LINEARITY CONTROL
    K Number
    K920285
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Phoenix Diagnostics, Inc.
    Date Received
    January 22, 1992
    Decision Date
    July 14, 1992
    Product Code
    JJS
    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
    JJS Controls For Blood-Gases, (Assayed And Unassayed)

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    Other Clearances by Phoenix Diagnostics, Inc.

    K Number Device Name
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    K020148 pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
    K020129 PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
    K013451 PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
    K012987 PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
    K012509 PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM
    K960592 ELECTROLYTE STANDARDS
    K945860 SPECTRUM CO-OXIMETER LINEARITY CONTROL
    K912718 ENZYME LINEARITY CONTROL
    Search all 21 clearances from Phoenix Diagnostics, Inc. →