Product code DIG— Clinical Toxicology

COZART EIA OPIATES ORAL FLUID KIT

Classification name
Cholinesterase Test Paper
Device class
Class 1
Regulation
21 CFR 862.3240
Advisory panel
Clinical Toxicology
Total cleared
1
First cleared
Most recent

Market context for product code DIG

FDA has cleared 1 device under product code DIG, all in 2003, filed by 1 applicant company. 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.

Top applicants under product code DIG

Recent clearances under product code DIG

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