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

    RIA FOR FOLATES & VIT. B12, COMBO KIT

    K Number: K780148 · Decision Mar 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    63
    Applicant Total
    9
    Review Days
    32

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    Basic Information

    Device Name
    RIA FOR FOLATES & VIT. B12, COMBO KIT
    K Number
    K780148
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1295
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Ria Products, Inc.
    Date Received
    January 30, 1978
    Decision Date
    March 3, 1978
    Product Code
    CGN
    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
    CGN Acid, Folic, Radioimmunoassay

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    K801578 COMBOSTAT - NO-BOIL KIT
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    K781844 FERRITIN KIT
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