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

    FERRITIN RIA KIT

    K Number: K791860 · Decision Dec 6, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    86
    Applicant Total
    9
    Review Days
    78

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    Basic Information

    Device Name
    FERRITIN RIA KIT
    K Number
    K791860
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Cis Radiopharmaceuticals, Inc.
    Date Received
    September 19, 1979
    Decision Date
    December 6, 1979
    Product Code
    DBF
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DBF Ferritin, Antigen, Antiserum, Control

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    Other Clearances by Cis Radiopharmaceuticals, Inc.

    K Number Device Name
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    K791202 RIA KIT FOR TRYPSIN
    K792000 LUTEINIZING HORMONE (LH) RIA
    K791051 PROGESTERONE RADIOIMMUNOASSAY KIT
    K790003 RIA KIT, PROLACTIN
    K780982 KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT
    K771878 IRIDIUM 192 WIRES & PINS
    K760251 SET, ORAL ADMINISTRATION