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

    OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test

    K Number: K181436 · Decision Jun 22, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    58
    Applicant Total
    6
    Review Days
    21

    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
    OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
    K Number
    K181436
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5640
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SEKISUI Diagnostics, LLC
    Date Received
    June 1, 2018
    Decision Date
    June 22, 2018
    Product Code
    KTN
    Advisory Committee
    Immunology
    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
    KTN System, Test, Infectious Mononucleosis

    Similar 510(k) Clearances

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

    ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)

    FDA 510(k)
    FDA Class 2 ·Immunology

    BIORAPID MONONUCLEOSIS

    FDA 510(k)
    FDA Class 2 ·Immunology

    COLOR-MONOGEN

    FDA 510(k)
    FDA Class 2 ·Immunology

    DRYSPOT INFECTIOUS MONONUCLEOSIS KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    CLEARVIEW IM

    FDA 510(k)
    FDA Class 2 ·Immunology

    MONOCOL/LEX-IM TEST

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

    Other Clearances by SEKISUI Diagnostics, LLC

    K Number Device Name
    K241188 Acucy® Influenza A&B Test with the Acucy® 2 System
    K192719 Osom Ultra Plus Flu A&B Test Kit
    K182001 Acucy Influenza A&B Test with the Acucy System
    K121397 OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
    K123182 OSOM INFLUENZA A&B TEST MODEL 190