Data / Medical devices / Analyzer, Chemistry, Centrifugal, For Clinical Use
Analyzer, Chemistry, Centrifugal, For Clinical Use (JJG): 10 FDA-registered makers in 5 countries
10 establishments in 5 countries are registered with the FDA to make Analyzer, Chemistry, Centrifugal, For Clinical Use (product code JJG, Class 1, 21 CFR 862.2140). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 30 510(k) clearances under this code, the latest on August 28, 1997, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JJG
- Device class
- 1
- Regulation
- 862.2140
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| India | 3 |
| China | 2 |
| Italy | 1 |
| Taiwan | 1 |
Makers of Analyzer, Chemistry, Centrifugal, For Clinical Use
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 |
|---|---|---|---|---|---|---|---|---|
| Abaxis, Inc. | Union City, CA, United States | Manufacturer | 2 | March 13, 1995 | 0 | 1 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 1 | January 8, 1986 | 0 | 0 | 0 | api.fda.gov |
| Accuster Technologies Pvt. Ltd. | New Delhi, India | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huzhou Junda Industry Co., Ltd. | Anji Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Q-Line Biotech Limited | Lucknow Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Silfradent SRL | S.Sofia Forli, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TST Biomedical Electronics Co., Ltd. | Taoyuan, Taiwan | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 28, 1997. 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.