NTYClass II
System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
21 CFR 866.6010 / Immunology
NTY is the FDA product code for System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer, a class II device type, regulated under 21 CFR 866.6010. FDA's definition for this code reads: "MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- NTY
- Device name
- System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
- FDA definition
- MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES.
- Regulation
- 21 CFR 866.6010
- Device class
- Class II
- Review panel
- Immunology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code NTY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2008 | 1 |
Applicants with the most clearances
Product code NTY| Applicant | Clearances |
|---|---|
| Amdl, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code NTY.
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