FDA product code NTY: System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
NTY is the FDA product code for system, test, fibrin/fibrinogen degradation products for monitoring of colorectal cancer. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under NTY. The average 510(k) review took 264 days (median 264).
Definition
MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer |
| Device class | Class II |
| Regulation | 21 CFR 866.6010 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NTY clearance
Top NTY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Amdl, Inc. | 1 | 2008-07-01 |
Most recent NTY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072901 | Amdl, Inc. | AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 | 2008-07-01 | 264 |
Recalls for NTY devices
openFDA lists no recalls for product code NTY.
Frequently asked questions
What is FDA product code NTY?
NTY is the FDA product code for system, test, fibrin/fibrinogen degradation products for monitoring of colorectal cancer. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is NTY?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code NTY?
Across 1 cleared submissions the average was 264 days from receipt to decision (median 264).
Which companies have the most NTY clearances?
Amdl, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NTY
- Run a recall and safety report across every NTY manufacturer
- Watch product code NTY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times