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

    Ion PGM Dx System

    K Number: K170299 · Decision Jun 22, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    1
    Applicant Total
    7
    Review Days
    142

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    Basic Information

    Device Name
    Ion PGM Dx System
    K Number
    K170299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.2265
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Life Technologies Corporation
    Date Received
    January 31, 2017
    Decision Date
    June 22, 2017
    Product Code
    PFF
    Advisory Committee
    Immunology
    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
    PFF High Throughput Dna Sequence Analyzer

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