FDA product code LFO: Nephelometric Inhibition Immunoassay, Diphenylhydantoin
LFO is the FDA product code for nephelometric inhibition immunoassay, diphenylhydantoin. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under LFO. The average 510(k) review took 123 days (median 123).
Classification
| Field | Value |
|---|---|
| Device name | Nephelometric Inhibition Immunoassay, Diphenylhydantoin |
| Device class | Class II |
| Regulation | 21 CFR 862.3350 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LFO clearance
Top LFO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coulter Electronics, Inc. | 1 | 1988-05-27 |
Most recent LFO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880294 | Coulter Electronics, Inc. | DART PHENYTOIN | 1988-05-27 | 123 |
Recalls for LFO devices
openFDA lists no recalls for product code LFO.
Frequently asked questions
What is FDA product code LFO?
LFO is the FDA product code for nephelometric inhibition immunoassay, diphenylhydantoin. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel.
What device class is LFO?
Class II, regulation 21 CFR 862.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFO?
Across 1 cleared submissions the average was 123 days from receipt to decision (median 123).
Which companies have the most LFO clearances?
Coulter Electronics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LFO
- Run a recall and safety report across every LFO manufacturer
- Watch product code LFO 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.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times