NAOClass I
Test, Carbohydrate Deficient Transferrin
21 CFR 862.1360 / Clinical Chemistry
NAO is the FDA product code for Test, Carbohydrate Deficient Transferrin, a class I device type, regulated under 21 CFR 862.1360. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- NAO
- Device name
- Test, Carbohydrate Deficient Transferrin
- Regulation
- 21 CFR 862.1360
- Device class
- Class I
- Review panel
- Clinical Chemistry
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 2
Clearances, product code NAO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 1 |
| 2006 | 1 |
Applicants with the most clearances
Product code NAO| Applicant | Clearances |
|---|---|
| Axis | 1 |
| Siemens Healthcare Diagnostics Inc. | 1 |
| Sangui Biotech, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
