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

    GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL

    K Number: K063224 · Decision Dec 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    59

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    Basic Information

    Device Name
    GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
    K Number
    K063224
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5910
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gentris Corporation
    Date Received
    October 24, 2006
    Decision Date
    December 22, 2006
    Product Code
    NZB
    Advisory Committee
    Microbiology
    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
    NZB Quality Control Material, Genetics, Dna

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