LAZ · Class I · 21 CFR 862.3280

FDA Product Code LAZ: N-acetylprocainamide Control Materials

Leading manufacturers include Syva Co. and Changzhou Universal Medical Equipment Co., Ltd..

4
Total
4
Cleared
46d
Avg days
1981
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared N-acetylprocainamide Control Materials Devices (Product Code LAZ)

4 devices
1–4 of 4
Cleared Sep 23, 2021
Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
K211667
Changzhou Universal Medical Equipment Co., Ltd.
General & Plastic Surgery · 114d
Cleared Nov 29, 1982
ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL
K823127
Syva Co.
Toxicology · 35d
Cleared Jun 09, 1981
EMIT-AND METHOTREXATE CONTROL
K811461
Syva Co.
Toxicology · 14d

About Product Code LAZ - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code LAZ since 1981, with 4 receiving FDA clearance (average review time: 46 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.