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

    FOB ONE STEP RAPID TEST

    K Number: K110309 · Decision Sep 14, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    96
    Applicant Total
    1
    Review Days
    224

    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
    FOB ONE STEP RAPID TEST
    K Number
    K110309
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orient Gene Biotech
    Date Received
    February 2, 2011
    Decision Date
    September 14, 2011
    Product Code
    KHE
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KHE Reagent, Occult Blood

    Similar 510(k) Clearances

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

    Instant-view-PLUS immunochemical Fecal Occult Blood Test

    FDA 510(k)
    FDA Class 2 ·Hematology

    InSure ONE

    FDA 510(k)
    FDA Class 2 ·Hematology

    hema-screen SPECIFIC Gold

    FDA 510(k)
    FDA Class 2 ·Hematology

    Wondfo One Step Fecal Occult Blood (FOB) Test

    FDA 510(k)
    FDA Class 2 ·Hematology

    hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

    FDA 510(k)
    FDA Class 2 ·Hematology

    OC-Light S FIT

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