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

    MONODEX

    K Number: K894793 · Decision Aug 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    58
    Applicant Total
    5
    Review Days
    24

    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
    MONODEX
    K Number
    K894793
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5640
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Cenogenics Corp.
    Date Received
    July 28, 1989
    Decision Date
    August 21, 1989
    Product Code
    KTN
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    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.

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

    FDA 510(k)
    FDA Class 2 ·Immunology

    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
    View all

    Other Clearances by Cenogenics Corp.

    K Number Device Name
    K042641 CHEMVIEW-10
    K030533 ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST
    K992397 ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
    K843680 URI-VAL