BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5

    K Number: K231806 · Decision Mar 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    327
    Applicant Total
    7
    Review Days
    276

    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
    Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
    K Number
    K231806
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1620
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oxoid Limited (Part of Thermo Fisher Scientific)
    Date Received
    June 20, 2023
    Decision Date
    March 22, 2024
    Product Code
    JTN
    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
    JTN Susceptibility Test Discs, Antimicrobial

    Similar 510(k) Clearances

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

    HardyDisk AST Gepotidacin 10µg (GEP10)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HardyDisk AST Cefiderocol 30µg (FDC30)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Sulopenem SPM 2 µg

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HardyDisk AST Gepotidacin 10µg (GEP10)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Ceftobiprole BPR 5 µg Disc

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

    Other Clearances by Oxoid Limited (Part of Thermo Fisher Scientific)

    K Number Device Name
    K232276 Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
    K203336 Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
    K210873 Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
    K203700 Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
    K193508 Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
    K181975 Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30