DJZ · Class I · 21 CFR 862.3050

FDA Product Code DJZ: Devices, Breath Trapping, Alcohol

Leading manufacturers include Pas Systems International, Inc., ACON Laboratories, Inc. and Seju Engineering Co., Ltd..

28
Total
28
Cleared
144d
Avg days
2004
Since

FDA 510(k) Cleared Devices, Breath Trapping, Alcohol Devices (Product Code DJZ)

28 devices
1–24 of 28
Cleared Apr 29, 2013
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
K123470
Pas Systems International, Inc.
Toxicology · 167d
Cleared Nov 21, 2011
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
K110614
Seju Engineering Co., Ltd.
Chemistry · 263d
Cleared Jan 28, 2010
MISSION BREATH ALCOHOL DETECTOR
K093143
ACON Laboratories, Inc.
Toxicology · 115d

About Product Code DJZ - Regulatory Context