BEUDAMED
    Product Code: NTY FDA class 2 21 CFR 866.6010

    System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer

    Immunology

    The Fibrin/Fibrinogen Degradation Products Test System for Colorectal Cancer Monitoring is a diagnostic device used to monitor colorectal cancer patients after therapy for disease progression, used in conjunction with other diagnostic modalities. It measures fibrin and fibrinogen degradation products as tumor-associated markers in the oncology setting. It is an FDA Class 2 device regulated under 21 CFR 866.6010 in the Immunology specialty, with product code NTY, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Research product code NTY in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    NTY
    Device Class
    FDA class 2
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K072901 AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101