Data / Medical devices / High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs (LFI): 7 FDA-registered makers in 1 country
7 establishments in 1 country are registered with the FDA to make High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs (product code LFI, Class 2, 21 CFR 862.3910). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on March 20, 1995, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- LFI
- Device class
- 2
- Regulation
- 862.3910
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
Makers of High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtox Diagnostics, Inc. | Burlington, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtox Diagnostics, Inc. | Burlington, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nano-Ditech Corporation | Cranbury, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Princeton BioMeditech Corp. | Plainsboro, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Princeton BioMeditech Corp. | Skillman, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 20, 1995. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.