FDA product code LFN: Nephelometric Inhibition Immunoassay, Phenobarbital
LFN is the FDA product code for nephelometric inhibition immunoassay, phenobarbital. It is a Class II device, regulated under 21 CFR 862.3660 and reviewed by the Clinical Toxicology panel. FDA has cleared 5 510(k) submissions under LFN, from 4 different applicants. The average 510(k) review took 58 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Nephelometric Inhibition Immunoassay, Phenobarbital |
| Device class | Class II |
| Regulation | 21 CFR 862.3660 |
| 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 LFN clearance
Top LFN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 1986-02-28 |
| Seradyn, Inc. | 1 | 1994-02-25 |
| Coulter Electronics, Inc. | 1 | 1987-01-13 |
| Electro-Nucleonics Laboratories, Inc. | 1 | 1982-06-03 |
Most recent LFN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934388 | Seradyn, Inc. | QMS PHENOBARBITAL | 1994-02-25 | 169 |
| K864612 | Coulter Electronics, Inc. | DART PHENOBARBITAL ASSAY SYSTEM | 1987-01-13 | 50 |
| K860304 | E.I. Dupont DE Nemours & Co., Inc. | DUPONT PHENOBARBITAL ASSAY | 1986-02-28 | 31 |
| K860303 | E.I. Dupont DE Nemours & Co., Inc. | DUPONT PHENOBARBITAL CALIBRATOR | 1986-02-28 | 31 |
| K821543 | Electro-Nucleonics Laboratories, Inc. | IPA FOR DETECTION OF PHENOBARBITAL | 1982-06-03 | 10 |
Recalls for LFN devices
openFDA lists no recalls for product code LFN.
Frequently asked questions
What is FDA product code LFN?
LFN is the FDA product code for nephelometric inhibition immunoassay, phenobarbital. It is a Class II device, regulated under 21 CFR 862.3660 and reviewed by the Clinical Toxicology panel.
What device class is LFN?
Class II, regulation 21 CFR 862.3660. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFN?
Across 5 cleared submissions the average was 58 days from receipt to decision (median 31).
Which companies have the most LFN clearances?
E.I. Dupont DE Nemours & Co., Inc. (2); Seradyn, Inc. (1); Coulter Electronics, Inc. (1); Electro-Nucleonics Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LFN
- Run a recall and safety report across every LFN manufacturer
- Watch product code LFN 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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