NFX — Test, Cholesterol, Total, Over The Counter Class I
FDA product code NFX covers "Test, Cholesterol, Total, Over The Counter", a Class I medical device regulated under 21 CFR 862.1175. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NFX
- Device Class
- Class I
- Regulation Number
- 862.1175
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K033899 | lifestream technologies | LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONI | May 20, 2004 |