DeviceClearance

Product code DJZ— Clinical Toxicology

ALCO TUBE PLUS

Classification name
Devices, Breath Trapping, Alcohol
Device class
Class 1
Regulation
21 CFR 862.3050
Advisory panel
Clinical Toxicology
Total cleared
28
First cleared
Most recent

Market context for product code DJZ

FDA has cleared 28 devices under product code DJZ between 2004 and 2016, filed by 20 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 DJZ

Recent clearances under product code DJZ

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