Product code LFH
- Device name
- U.V. Spectrometry, 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#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231020 | Alinity c Tricyclic Antidepressants Reagent Kit | Microgenics Corporation | 2023-11-17 |
| K213875 | DRI TM Tricyclics Serum Tox Assay | Microgenics Corporation | 2022-12-21 |
| K983268 | MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY | Diagnostic Reagents, Inc. | 1998-11-18 |
| K981801 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | Princeton BioMeditech Corp. | 1998-08-25 |
| K961393 | TRICYCLICS SERUM TOX ASSAY | Diagnostic Reagents, Inc. | 1996-06-12 |
| K953761 | AXSYM TRICYCLIC ANTIDEPRESSANTS | Abbott Laboratories | 1995-11-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10868348000253 | Status Toxi Cup | Lifesign L.L.C. | 2017-05-17 |
| 00868348000256 | Status Toxi Cup | Lifesign L.L.C. | 2017-05-17 |
| 00816565020960 | Fastect II Drug Screen Dipstick Test | AMEDITECH INC. | 2017-03-31 |
| 00748349000311 | QuikScreen | SYNTRON BIORESEARCH, INC. | 2017-02-27 |
| 00748349000274 | QuikScreen | SYNTRON BIORESEARCH, INC. | 2017-02-24 |
| 00748349000243 | QuikScreen | SYNTRON BIORESEARCH, INC. | 2016-12-13 |
| 00748349000199 | QuikScreen | SYNTRON BIORESEARCH, INC. | 2016-11-04 |
| 20748349000179 | QuikScreen Multi 12 Drug Cup Test | SYNTRON BIORESEARCH, INC. | 2016-10-21 |
| 00748349000175 | QuikScreen Multi 12 Drug Cup Test | SYNTRON BIORESEARCH, INC. | 2016-10-21 |
| 20748349000117 | QuikScreen | SYNTRON BIORESEARCH, INC. | 2016-10-04 |
| 00748349000106 | QuikScreen Multi 11 Drug Cup Test | SYNTRON BIORESEARCH, INC. | 2016-10-04 |
| 00748349000113 | QuikScreen | SYNTRON BIORESEARCH, INC. | 2016-10-04 |
| 10864040000348 | QTEST 12 (25 Pack) | MEDIMPEX UNITED, INC | 2016-09-30 |
| 10864040000331 | QTEST 11 (25 pack) | MEDIMPEX UNITED, INC | 2016-09-30 |
| 00863480002113 | Status Toxi Cup 13+4 | Lifesign L.L.C. | 2016-09-24 |
| 20863480002117 | Status Toxi Cup 13+4 | Lifesign L.L.C. | 2016-09-24 |
| 00863480002106 | LifeSign QuikScreen 11 | Lifesign L.L.C. | 2016-09-24 |
| 00842768001277 | Syva® RapidTest d.a.u.® TCA | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 10763924086532 | ACCUTEST - 5 Drug Test Cup *CLIA-Waived* | JANT PHARMACAL CORPORATION | 2016-09-23 |
| 10763924823533 | ACCUTEST Drug Test Cup 13-Panel CLIA-Waived | JANT PHARMACAL CORPORATION | 2016-09-23 |
| 10763924822536 | ACCUTEST Drug Test Cup 12-Panel CLIA-Waived | JANT PHARMACAL CORPORATION | 2016-09-23 |
| 10763924811530 | ACCUTEST Drug Test Cup 11-Panel CLIA-Waived | JANT PHARMACAL CORPORATION | 2016-09-23 |
| 10763924087539 | ACCUTEST - 6 Drug Cup | JANT PHARMACAL CORPORATION | 2016-09-23 |
| 00817405020010 | Alere iCup Dx 14 | Instant Technologies, Inc. | 2016-09-19 |
| 00817405020027 | Alere iCup Dx 14 | Instant Technologies, Inc. | 2016-09-19 |
| 00817405020126 | Alere iScreen Dx | Instant Technologies, Inc. | 2016-09-19 |
| 00817405020171 | Alere iScreen Dx | Instant Technologies, Inc. | 2016-09-19 |
| 00884883001183 | DRI Tricyclics Serum Tox Assay | Microgenics Corporation | 2016-09-12 |
| 00816610020235 | CLIAwaived | Cliawaived, Inc. | 2016-09-01 |
| 00816555021052 | Fastect II Drug Screen Dipstick Test | BRANAN MEDICAL CORPORATION | 2016-08-01 |