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

    I-STAT SYSTEM

    K Number: K973292 · Decision Oct 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    6
    Applicant Total
    14
    Review Days
    48

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    Basic Information

    Device Name
    I-STAT SYSTEM
    K Number
    K973292
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    I-Stat Corp.
    Date Received
    September 2, 1997
    Decision Date
    October 20, 1997
    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

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    Other Clearances by I-Stat Corp.

    K Number Device Name
    K012478 MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER
    K011478 I-STAT SYSTEM
    K001387 I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
    K001154 I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
    K992571 I-STAT SYSTEM
    K982071 I-STAT LACTATE TEST
    K940918 I-STAT 200 PORTABLE CLINICAL ANALYZER
    K936081 I-STAT TESTS FOR ACID-BASE PARAMETERS
    K934642 I-STAT IONIZED CALCIUM TEST
    K934641 I-STAT CONTROL LEVELS 1,2,3
    Search all 14 clearances from I-Stat Corp. →