510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DJZClass I

Devices, Breath Trapping, Alcohol

21 CFR 862.3050 / Clinical Toxicology
FDA source (opens on fda.gov)

DJZ is the FDA product code for Devices, Breath Trapping, Alcohol, a class I device type, regulated under 21 CFR 862.3050. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
DJZ
Device name
Devices, Breath Trapping, Alcohol
Regulation
21 CFR 862.3050
Device class
Class I
Review panel
Clinical Toxicology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
28
Ingested recalls
3

Clearances, product code DJZ

By decision year
28 clearances under product code DJZ with a decision year between 2004 and 2016, 2006 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code DJZ by decision year
YearClearances
20041
20052
20066
20072
20085
20095
20102
20113
20131
20161

Applicants with the most clearances

Product code DJZ
Applicants holding the most 510(k) clearances under product code DJZ
ApplicantClearances
KHN Solutions LLC4
Akers Biosciences, Inc.3
Sentech Korea Corp.3
Q3 Innovations, LLC2
Acon Laboratories, Inc.1
AlcoPro Inc1
Alcotest Quebec1
Canada, Inc.1
Connectables, LLC1
Contralco1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 42 companies shown, in name order