FDA product code LEQ: Detectors, Electrochemical, Liquid Chromatography
LEQ is the FDA product code for detectors, electrochemical, liquid chromatography. It is a Class I device, regulated under 21 CFR 862.2260 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under LEQ, from 3 different applicants. The average 510(k) review took 62 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Detectors, Electrochemical, Liquid Chromatography |
| Device class | Class I |
| Regulation | 21 CFR 862.2260 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LEQ clearance
Top LEQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Esa, Inc. | 2 | 1990-09-27 |
| Waters Corporation | 1 | 1996-07-22 |
| Environmental Sciences Assoc., Inc. | 1 | 1980-07-21 |
Most recent LEQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962574 | Waters Corporation | WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) | 1996-07-22 | 21 |
| K903231 | Esa, Inc. | COULOCHEM II | 1990-09-27 | 66 |
| K864729 | Esa, Inc. | NEUROCHEMICAL ANALYZER | 1987-04-13 | 130 |
| K801439 | Environmental Sciences Assoc., Inc. | MODEL 5100 ELECTROCHEMICAL DETECTOR | 1980-07-21 | 31 |
Recalls for LEQ devices
openFDA lists no recalls for product code LEQ.
Frequently asked questions
What is FDA product code LEQ?
LEQ is the FDA product code for detectors, electrochemical, liquid chromatography. It is a Class I device, regulated under 21 CFR 862.2260 and reviewed by the Clinical Toxicology panel.
What device class is LEQ?
Class I, regulation 21 CFR 862.2260. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LEQ?
Across 4 cleared submissions the average was 62 days from receipt to decision (median 48).
Which companies have the most LEQ clearances?
Esa, Inc. (2); Waters Corporation (1); Environmental Sciences Assoc., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LEQ
- Run a recall and safety report across every LEQ manufacturer
- Watch product code LEQ 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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