DeviceClearance

Product code NTY— Immunology

AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101

Classification name
System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
Device class
Class 2
Regulation
21 CFR 866.6010
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code NTY under 21 CFR 866.6010, via openFDA

Market context for product code NTY

FDA has cleared 1 device under product code NTY, all in 2008, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NTY

Recent clearances under product code NTY

Data sourced from openFDA. This site is unofficial and independent of the FDA.