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

    I-STAT SYSTEM

    K Number: K992571 · Decision Feb 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    23
    Applicant Total
    14
    Review Days
    192

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    Basic Information

    Device Name
    I-STAT SYSTEM
    K Number
    K992571
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7140
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I-Stat Corp.
    Date Received
    August 2, 1999
    Decision Date
    February 10, 2000
    Product Code
    JBP
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JBP Activated Whole Blood Clotting Time

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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
    K982071 I-STAT LACTATE TEST
    K973292 I-STAT SYSTEM
    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. →