Product code DIE— Clinical Toxicology

SHAPE-ACTIO METAL TOXICOLOGY CONTROL

Classification name
Heavy Metals Control Materials
Device class
Class 1
Regulation
21 CFR 862.3280
Advisory panel
Clinical Toxicology
Total cleared
5
First cleared
Most recent

Market context for product code DIE

FDA has cleared 5 devices under product code DIE between 1986 and 2002, 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 DIE

Recent clearances under product code DIE

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