NTY — System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer Class II
FDA product code NTY covers "System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer", a Class II medical device regulated under 21 CFR 866.6010. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NTY
- Device Class
- Class II
- Regulation Number
- 866.6010
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K072901 | amdl | AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 | July 1, 2008 |