FDA product code LES: Fluorescent Immunoassay, Diphenylhydantoin
LES is the FDA product code for fluorescent immunoassay, diphenylhydantoin. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel. FDA has cleared 7 510(k) submissions under LES, from 5 different applicants. The average 510(k) review took 22 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Fluorescent 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 LES clearance
Top LES applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 2 | 1985-01-23 |
| Miles Laboratories, Inc. | 2 | 1981-04-29 |
| Sclavo, Inc. | 1 | 1987-01-13 |
| American Dade | 1 | 1983-05-16 |
| American Diagnostic Corp. | 1 | 1981-12-31 |
Most recent LES clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K865102 | Sclavo, Inc. | IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS | 1987-01-13 | 20 |
| K844990 | Syva Co. | SYVA ADVANCE EMIT PHENYTOIN ASSAY | 1985-01-23 | 28 |
| K831154 | American Dade | STRATUS PHENYTOIN FLUOROMETRIC ENZYME | 1983-05-16 | 38 |
| K820187 | Syva Co. | SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY | 1982-02-12 | 18 |
| K813538 | American Diagnostic Corp. | PHENYTOIN FLUORESCENT IMMUNOASSAY | 1981-12-31 | 10 |
Recalls for LES devices
openFDA lists no recalls for product code LES.
Frequently asked questions
What is FDA product code LES?
LES is the FDA product code for fluorescent 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 LES?
Class II, regulation 21 CFR 862.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code LES?
Across 7 cleared submissions the average was 22 days from receipt to decision (median 20).
Which companies have the most LES clearances?
Syva Co. (2); Miles Laboratories, Inc. (2); Sclavo, Inc. (1); American Dade (1); American Diagnostic Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LES
- Run a recall and safety report across every LES manufacturer
- Watch product code LES 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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