FDA product code LAI: Thin Layer Chromatography, Opiates
LAI is the FDA product code for thin layer chromatography, opiates. It is a Class II device, regulated under 21 CFR 862.3650 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under LAI. The average 510(k) review took 141 days (median 141).
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Opiates |
| Device class | Class II |
| Regulation | 21 CFR 862.3650 |
| 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 LAI clearance
Top LAI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Toxi-Lab, Inc. | 1 | 1993-09-24 |
Most recent LAI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932209 | Toxi-Lab, Inc. | TOXI*LAB LTD OPIATE SYSTEM | 1993-09-24 | 141 |
Recalls for LAI devices
openFDA lists no recalls for product code LAI.
Frequently asked questions
What is FDA product code LAI?
LAI is the FDA product code for thin layer chromatography, opiates. It is a Class II device, regulated under 21 CFR 862.3650 and reviewed by the Clinical Toxicology panel.
What device class is LAI?
Class II, regulation 21 CFR 862.3650. Typical premarket route: 510(k).
How long does a 510(k) take for product code LAI?
Across 1 cleared submissions the average was 141 days from receipt to decision (median 141).
Which companies have the most LAI clearances?
Toxi-Lab, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LAI
- Run a recall and safety report across every LAI manufacturer
- Watch product code LAI 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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