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

    iC-GPC Assay TM for use on the iC-SystemTM

    K Number: K163390 · Decision Aug 8, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    249

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    Basic Information

    Device Name
    iC-GPC Assay TM for use on the iC-SystemTM
    K Number
    K163390
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3365
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Icubate, Inc.
    Date Received
    December 2, 2016
    Decision Date
    August 8, 2017
    Product Code
    PAM
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PAM Gram-Positive Bacteria And Their Resistance Markers

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    Other Clearances by Icubate, Inc.

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