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

    IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE

    K Number: K013938 · Decision Jan 28, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    26
    Applicant Total
    7
    Review Days
    61

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    Basic Information

    Device Name
    IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
    K Number
    K013938
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1450
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diametrics Medical, Inc.
    Date Received
    November 28, 2001
    Decision Date
    January 28, 2002
    Product Code
    KHP
    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
    KHP Acid, Lactic, Enzymatic Method

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    Other Clearances by Diametrics Medical, Inc.

    K Number Device Name
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    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