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

    SOLID PHASE SIMUL TRAC VITAMIN B12

    K Number: K822728 · Decision Nov 5, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    63
    Applicant Total
    632
    Review Days
    58

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    Basic Information

    Device Name
    SOLID PHASE SIMUL TRAC VITAMIN B12
    K Number
    K822728
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1295
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    September 8, 1982
    Decision Date
    November 5, 1982
    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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