Data / Medical devices / Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase (DLI): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase (product code DLI, Class 1, 21 CFR 862.3240). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on March 15, 1995, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DLI
- Device class
- 1
- Regulation
- 862.3240
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| Hong Kong | 4 |
| United States | 2 |
| China | 1 |
| Italy | 1 |
Makers of Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
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 |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 1 | March 15, 1995 | 0 | 0 | 0 | api.fda.gov |
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gorgeous Beauty Equipment Manufacture Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Mita Biotechnology Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Mita Technology Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Tuosite Technology Co.,ltd | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oman Medical Beauty Manufacture Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sentinel CH. SPA | Milano, Italy | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 15, 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.