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

    PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT

    K Number: K923569 · Decision Aug 26, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    45
    Applicant Total
    72
    Review Days
    40

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    Basic Information

    Device Name
    PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT
    K Number
    K923569
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1415
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Diagnostics, Inc.
    Date Received
    July 17, 1992
    Decision Date
    August 26, 1992
    Product Code
    JMO
    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
    JMO Ferrozine (Colorimetric) Iron Binding Capacity

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    Other Clearances by Baxter Diagnostics, Inc.

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    K935704 DRIED GRAM-NEGATIVE MIC//COMBO PANELS
    K950570 STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
    K945235 DRIED GRAM-POSITIVE MIC/COMBO PANELS
    K941030 DRIED GRAM-NEGATIVE CEFPODOXIME
    K940917 LORACARBEF GRAM-NAGATIVE PANELS
    K941459 GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX
    K941317 DRIED GRAM NEGATIVE/CEFMETAZOLE
    K942089 MICRODILUTION/LORACARBEF PANELS
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