FDA product code LAE: High Pressure Liquid Chromatography, Codeine
LAE is the FDA product code for high pressure liquid chromatography, codeine. It is a Class II device, regulated under 21 CFR 862.3270 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under LAE, from 2 different applicants. The average 510(k) review took 48 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | High Pressure Liquid Chromatography, Codeine |
| Device class | Class II |
| Regulation | 21 CFR 862.3270 |
| 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 LAE clearance
Top LAE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vygon Corp. | 1 | 1985-05-07 |
| Mem, Inc. | 1 | 1983-10-14 |
Most recent LAE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851480 | Vygon Corp. | VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW | 1985-05-07 | 22 |
| K832590 | Mem, Inc. | MOUTH-TO-MOUTH SHIELD APPLICATOR | 1983-10-14 | 73 |
Recalls for LAE devices
openFDA lists no recalls for product code LAE.
Frequently asked questions
What is FDA product code LAE?
LAE is the FDA product code for high pressure liquid chromatography, codeine. It is a Class II device, regulated under 21 CFR 862.3270 and reviewed by the Clinical Toxicology panel.
What device class is LAE?
Class II, regulation 21 CFR 862.3270. Typical premarket route: 510(k).
How long does a 510(k) take for product code LAE?
Across 2 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most LAE clearances?
Vygon Corp. (1); Mem, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LAE
- Run a recall and safety report across every LAE manufacturer
- Watch product code LAE 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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