NFXClass I
Test, Cholesterol, Total, Over The Counter
21 CFR 862.1175 / Clinical Chemistry
NFX is the FDA product code for Test, Cholesterol, Total, Over The Counter, a class I device type, regulated under 21 CFR 862.1175. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- NFX
- Device name
- Test, Cholesterol, Total, Over The Counter
- Regulation
- 21 CFR 862.1175
- Device class
- Class I
- Review panel
- Clinical Chemistry
- 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 NFX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2004 | 1 |
Applicants with the most clearances
Product code NFX| Applicant | Clearances |
|---|---|
| Lifestream Technologies, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code NFX.
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
