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

    NO-HOIL COMBOSTAT II KIT

    K Number: K813310 · Decision Dec 17, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    77
    Applicant Total
    9
    Review Days
    23

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    Basic Information

    Device Name
    NO-HOIL COMBOSTAT II KIT
    K Number
    K813310
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1810
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Ria Products, Inc.
    Date Received
    November 24, 1981
    Decision Date
    December 17, 1981
    Product Code
    CDD
    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
    CDD Radioassay, Vitamin B12

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    Other Clearances by Ria Products, Inc.

    K Number Device Name
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    K801578 COMBOSTAT - NO-BOIL KIT
    K800710 FERRITIRON KIT CAT. #RP-1100
    K800914 NO-BOIL FOLATE KIT #RP-500
    K781844 FERRITIN KIT
    K781769 IRON 59 KIT
    K780148 RIA FOR FOLATES & VIT. B12, COMBO KIT