LFH
6 FDA 510(k) clearances · Product code
103 daysmedian time to decision
373 days90th percentile
6clearances measured
FDA profile
- Official device name
- U.V. Spectrometry, Tricyclic Antidepressant Drugs
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3910
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Alinity c Tricyclic Antidepressants Reagent Kit (K231020) | Microgenics Corporation | 2023-11-17 |
| DRI TM Tricyclics Serum Tox Assay (K213875) | Microgenics Corporation | 2022-12-21 |
| MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY (K983268) | Diagnostic Reagents, Inc. | 1998-11-18 |
| ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (K981801) | Princeton BioMeditech Corp. | 1998-08-25 |
| TRICYCLICS SERUM TOX ASSAY (K961393) | Diagnostic Reagents, Inc. | 1996-06-12 |
| AXSYM TRICYCLIC ANTIDEPRESSANTS (K953761) | Abbott Laboratories | 1995-11-22 |
Track LFH automatically
Every clearance here is in the API, with alerts when new ones post.