Data / Medical devices / Cuvette, Thermostated
Cuvette, Thermostated (JRI): 15 FDA-registered makers in 6 countries
15 establishments in 6 countries are registered with the FDA to make Cuvette, Thermostated (product code JRI, Class 1, 21 CFR 862.2050). 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 December 14, 1987, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JRI
- Device class
- 1
- Regulation
- 862.2050
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 4 |
| United Kingdom | 2 |
| India | 1 |
| Turkey | 1 |
| Finland | 1 |
Makers of Cuvette, Thermostated
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 |
|---|---|---|---|---|---|---|---|---|
| Accuster Technologies Pvt. Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CARCLO TECHNICAL PLASTICS - Greensburg | Greensburg, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carclo Technical Plastics - Latrobe | Latrobe, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuve Sanayi Malzemeleri Imalat Ve Ticaret A.S. | Ankara, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Binding Site | Kings Norton Birmingham, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermo Fisher Scientific OY | VANTAA Uusimaa, Finland | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trademark Plastics Inc. | Riverside, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Binding Site Group Ltd. | Birmingham, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Biorear Biotechnology Co.ltd | Jiaxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Gongdong Medical Technology Co., Ltd | TAIZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 14, 1987. 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.