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

    TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL

    K Number: K913371 · Decision Nov 8, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    244
    Applicant Total
    27
    Review Days
    102

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    Basic Information

    Device Name
    TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL
    K Number
    K913371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Creative Laboratory Products, Inc.
    Date Received
    July 29, 1991
    Decision Date
    November 8, 1991
    Product Code
    JIT
    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
    JIT Calibrator, Secondary

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    Other Clearances by Creative Laboratory Products, Inc.

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    K913224 LIPID LINEARITY CONTROLS
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    K912823 HIGH DENSITY LIPOPROTEIN CHOLESTEROL
    K912725 TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL
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