NTY

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

Product code

NTY

Device name

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

Device class

Class 2

21 CFR

21 CFR 866.6010

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).