BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
FDA 510(k) clearance K053332 · decided 2006-01-20
Clearance details
- K-number
- K053332
- Device name
- BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
- Applicant
- Sentech Korea Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-01
- Decision date
- 2006-01-20
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- DJZ
- Device class
- 1
- Regulation number
- 862.3050
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Palisades Park, NJ, US
- Third-party review
- No
- Expedited review
- No
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| PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM (K110614) | Seju Engineering Co., Ltd. | 2011-11-21 |
| ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST (K102225) | Alcopro, Inc. | 2011-04-06 |
| BREATHSCN PRO (K102338) | Akers Biosciences, Inc. | 2011-01-12 |
| CONTRALCO (K100879) | Contralco | 2010-08-04 |
| MISSION BREATH ALCOHOL DETECTOR (K093143) | ACON Laboratories, Inc. | 2010-01-28 |
| ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 (K091714) | Skyfine Inc. Limited | 2009-11-18 |
| LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER (K090766) | Lifeloc Technologies, Inc. | 2009-07-23 |
| ALCO TUBE PLUS (K082080) | Alcotest Quebec | 2009-04-01 |
| BACTRACK SELECT BREATHALYZER, MODEL S80 (K090067) | Khn Solutions, LLC | 2009-03-24 |
| BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 (K083801) | Khn Solutions, LLC | 2009-03-19 |
Recalls involving this device
No recalls on record reference this clearance.