FDA product code LAX: Lidocaine Control Materials
LAX is the FDA product code for lidocaine control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under LAX. The average 510(k) review took 22 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Lidocaine Control Materials |
| Device class | Class I |
| Regulation | 21 CFR 862.3280 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LAX clearance
Top LAX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 1 | 1983-01-14 |
Most recent LAX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823865 | Syva Co. | ADVANCE SYS. EMIT-CAD LIDOCAINE CONTROL | 1983-01-14 | 22 |
Recalls for LAX devices
openFDA lists no recalls for product code LAX.
Frequently asked questions
What is FDA product code LAX?
LAX is the FDA product code for lidocaine control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel.
What device class is LAX?
Class I, regulation 21 CFR 862.3280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LAX?
Across 1 cleared submissions the average was 22 days from receipt to decision (median 22).
Which companies have the most LAX clearances?
Syva Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LAX
- Run a recall and safety report across every LAX manufacturer
- Watch product code LAX 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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