FDA product code LAZ: N-Acetylprocainamide Control Materials
LAZ is the FDA product code for n-acetylprocainamide control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under LAZ, from 3 different applicants. The average 510(k) review took 46 days (median 28). FDA has posted 1 recall for LAZ devices.
Classification
| Field | Value |
|---|---|
| Device name | N-Acetylprocainamide 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 |
510(k) clearances per year for LAZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 114 |
Compare with all 510(k) review times · Search every LAZ clearance
Top LAZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 2 | 1982-11-29 |
| Changzhou Universal Medical Equipment Co., Ltd. | 1 | 2021-09-23 |
| Vygon Corp. | 1 | 1985-05-07 |
Most recent LAZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211667 | Changzhou Universal Medical Equipment Co., Ltd. | Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) | 2021-09-23 | 114 |
| K851474 | Vygon Corp. | VYGON SPINAL ANESTHESIA TRAY CODE NO. 190 | 1985-05-07 | 22 |
| K823127 | Syva Co. | ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL | 1982-11-29 | 35 |
| K811461 | Syva Co. | EMIT-AND METHOTREXATE CONTROL | 1981-06-09 | 14 |
Recalls for LAZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-10-20.
Frequently asked questions
What is FDA product code LAZ?
LAZ is the FDA product code for n-acetylprocainamide 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 LAZ?
Class I, regulation 21 CFR 862.3280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LAZ?
Across 4 cleared submissions the average was 46 days from receipt to decision (median 28).
Which companies have the most LAZ clearances?
Syva Co. (2); Changzhou Universal Medical Equipment Co., Ltd. (1); Vygon Corp. (1).
Have LAZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2004-10-20.
Next steps
- Run an FDA pathway report with predicate devices for product code LAZ
- Run a recall and safety report across every LAZ manufacturer
- Watch product code LAZ 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.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times