DJZ · Class I · 21 CFR 862.3050

FDA Product Code DJZ: Devices, Breath Trapping, Alcohol

Leading manufacturers include Khn Solutions, LLC, Sentech Korea Corp. and Akers Biosciences, Inc..

28
Total
28
Cleared
144d
Avg days
2004
Since
28 devices
25–28 of 28
Cleared Jan 20, 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
K053332
Sentech Korea Corp.
Toxicology · 50d
Cleared Dec 09, 2005
BREATHKEY MODEL G10/BREATHKEY MODEL G30X
K052804
Omega Point Systems, LLC
Chemistry · 66d
Cleared Feb 09, 2005
ALCOHAWK PRECISION
K043188
Q3 Innovations, LLC
Chemistry · 84d
Cleared Aug 11, 2004
ALCOMATE, MODEL CA2000
K041334
Khn Solutions, LLC
Toxicology · 84d