FDA product code NFX: Test, Cholesterol, Total, Over The Counter
NFX is the FDA product code for test, cholesterol, total, over the counter. It is a Class I device, regulated under 21 CFR 862.1175 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under NFX. The average 510(k) review took 155 days (median 155).
Classification
| Field | Value |
|---|---|
| Device name | Test, Cholesterol, Total, Over The Counter |
| Device class | Class I |
| Regulation | 21 CFR 862.1175 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NFX clearance
Top NFX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lifestream Technologies, Inc. | 1 | 2004-05-20 |
Most recent NFX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033899 | Lifestream Technologies, Inc. | LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR | 2004-05-20 | 155 |
Recalls for NFX devices
openFDA lists no recalls for product code NFX.
Frequently asked questions
What is FDA product code NFX?
NFX is the FDA product code for test, cholesterol, total, over the counter. It is a Class I device, regulated under 21 CFR 862.1175 and reviewed by the Clinical Toxicology panel.
What device class is NFX?
Class I, regulation 21 CFR 862.1175. Typical premarket route: 510(k).
How long does a 510(k) take for product code NFX?
Across 1 cleared submissions the average was 155 days from receipt to decision (median 155).
Which companies have the most NFX clearances?
Lifestream Technologies, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NFX
- Run a recall and safety report across every NFX manufacturer
- Watch product code NFX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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