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

    J&S UIBC REAGENTS

    K Number: K912717 · Decision Sep 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    45
    Applicant Total
    18
    Review Days
    99

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    Basic Information

    Device Name
    J&S UIBC REAGENTS
    K Number
    K912717
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1415
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    J.S. Medical Assoc.
    Date Received
    June 18, 1991
    Decision Date
    September 25, 1991
    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 J.S. Medical Assoc.

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    K932551 ACCUTEX IM LATEX TEST
    K926112 ACCUTEX BETA-HCG TEST
    K924332 ACCUTEX CRP LATEX TEST
    K924247 ACCUTEX ASO LATEX TEST
    K924036 ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST
    K924037 ACCUTEX IM RBC TEST
    K924248 ACCUTEX SLE LATEX TEST
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