Product code LAZ— Clinical Toxicology

ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL

Classification name
N-Acetylprocainamide Control Materials
Device class
Class 1
Regulation
21 CFR 862.3280
Advisory panel
Clinical Toxicology
Total cleared
4
First cleared
Most recent

Market context for product code LAZ

FDA has cleared 4 devices under product code LAZ between 1981 and 2021, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code LAZ

Recent clearances under product code LAZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.