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

    CEDIA VITAMIN B12 (NO BOIL) ASSAY

    K Number: K951134 · Decision Jul 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    77
    Applicant Total
    107
    Review Days
    120

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    Basic Information

    Device Name
    CEDIA VITAMIN B12 (NO BOIL) ASSAY
    K Number
    K951134
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1810
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microgenics Corp.
    Date Received
    March 13, 1995
    Decision Date
    July 11, 1995
    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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