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

    IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE

    K Number: K030035 · Decision Jun 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    48
    Applicant Total
    7
    Review Days
    173

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    Basic Information

    Device Name
    IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
    K Number
    K030035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diametrics Medical, Inc.
    Date Received
    January 3, 2003
    Decision Date
    June 25, 2003
    Product Code
    JFY
    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
    JFY Enzymatic Method, Creatinine

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    Other Clearances by Diametrics Medical, Inc.

    K Number Device Name
    K013938 IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
    K011586 IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
    K981270 IRMA BLOOD ANALYSIS SYSTEM
    K980523 IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE
    K974396 IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE
    K945240 IRMA BLOOD ANALYSIS SYSTEM