510(k) K053332
- Device
- BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
- Applicant
- SENTECH KOREA CORP.
- 510(k) number
- K053332
- Product code
- DJZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-01-20
- Date received
- 2005-12-01
- Regulation
- 862.3050
- Classification name
- Devices, Breath Trapping, Alcohol
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MATTHEW SON
- Address
- 21 Grand Ave. Suite 103 Palisades Park NJ US 07650 07650
FDA Registration Numbers#
- 3030453686
- 3017676696
- 3012725363
- 3002956991
- 3043127647
- 3013036322
- 3009312584
- 3013019743
- 3004144955
- 3042256563
- 3016159411
- 3009585529
- 3009348423
- 3003483691
- 3012275122
- 1832216
- 1649661
- 3002653540
- 3007037208
- 3004847291
- 3003383868
- 3042276415
- 3030648160
- 2087572
- 3012073813
- 3014059993
- 3004077604
- 3014302776
- 3003309980
- 3003917514
- 9617268
- 3007798866
- 3010763671
- 2030633
- 3004848020
- 3007343307
- 1000655211
- 3013585270
- 3027519599
- 1054127
- 3010160538
Source Documents#
Other 510(k) Records For Product Code DJZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160613 | Soberlink Cellular Device and Sober Sky Web Portal | Soberlink Healthcare, LLC | 2016-07-14 |
| K123470 | PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE | Pas Systems International, Inc. | 2013-04-29 |
| K110614 | PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM | Seju Engineering Co., Ltd. | 2011-11-21 |
| K102225 | ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST | Alcopro, Inc. | 2011-04-06 |
| K102338 | BREATHSCN PRO | Akers Biosciences, Inc. | 2011-01-12 |
| K100879 | CONTRALCO | Contralco | 2010-08-04 |
| K093143 | MISSION BREATH ALCOHOL DETECTOR | ACON Laboratories, Inc. | 2010-01-28 |
| K091714 | ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 | Skyfine Inc. Limited | 2009-11-18 |
| K090766 | LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER | Lifeloc Technologies, Inc. | 2009-07-23 |
| K082080 | ALCO TUBE PLUS | Alcotest Quebec | 2009-04-01 |
| K090067 | BACTRACK SELECT BREATHALYZER, MODEL S80 | Khn Solutions, LLC | 2009-03-24 |
| K083801 | BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 | Khn Solutions, LLC | 2009-03-19 |
| K081855 | IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) | Canada, Inc. | 2008-12-19 |
| K082086 | KEY RING ALCOHOL BREATHALYZER | The Ashley Collection, Inc. | 2008-12-19 |
| K080848 | ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR | Q3 Innovations, LLC | 2008-07-25 |
Legacy Summary#
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FDA Review#
Decision Summary