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

    iC-GN iC-Cassette for use on the iC-System

    K Number: K190341 · Decision Jun 28, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    134

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    iC-GN iC-Cassette for use on the iC-System
    K Number
    K190341
    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
    February 14, 2019
    Decision Date
    June 28, 2019
    Product Code
    PEN
    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
    PEN Gram-Negative Bacteria And Associated Resistance Markers

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PEN), ordered by most recent decision date.

    LIAISON PLEX Gram-Negative Blood Culture Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BioFire Blood Culture Identification 2 (BCID2) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FilmArray Blood Culture Identification (BCID) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Icubate, Inc.

    K Number Device Name
    K163390 iC-GPC Assay TM for use on the iC-SystemTM