Product code MLK
- Device name
- Thin Layer Chromatography, Tricyclic Antidepressant Drugs
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3910
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00096295140583 | LEADER | Cardinal Health 110, Inc. | 2021-06-11 |
| 10743816001539 | Status DS™ TCA card | PRINCETON BIOMEDITECH CORPORATION | 2020-01-08 |
| 30014613337874 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 30014613337904 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 30014613337881 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 30014613337867 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 10743816000440 | Status DS™ 8 card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816000211 | AccuSign® TCA card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816000204 | AccuSign® TCA card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816000525 | StatusFirst™ 10 card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816000518 | AccuSign® DOA 10 card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816000501 | Status DS™ 10 card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816000488 | Status DS™ 10 card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816000471 | Status DS™ 9 card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816000464 | Status DS™ 9 card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816000457 | AccuSign® DOA 8 card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816000433 | Status DS™ 8 card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 00899722002757 | Alere Triage® | Alere San Diego, Inc. | 2016-09-21 |
| 00899722002771 | Alere Triage® | Alere San Diego, Inc. | 2016-09-20 |
| 00899722002764 | Alere Triage® | Alere San Diego, Inc. | 2016-09-20 |
| 00893038002135 | Alere Triage® | Alere San Diego, Inc. | 2016-09-19 |
| 00893038002098 | Alere Triage® | Alere San Diego, Inc. | 2016-09-19 |
| 00893038002104 | Alere Triage® | Alere San Diego, Inc. | 2016-09-19 |
| 00816555020109 | Monitect Drug Screen Cassette Test | BRANAN MEDICAL CORPORATION | 2016-08-01 |