Data / Medical devices / Nephelometer, For Clinical Use
Nephelometer, For Clinical Use (JQX): 12 FDA-registered makers in 5 countries
12 establishments in 5 countries are registered with the FDA to make Nephelometer, For Clinical Use (product code JQX, Class 1, 21 CFR 862.2700). 1 of them has a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on August 21, 1996, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JQX
- Device class
- 1
- Regulation
- 862.2700
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| China | 2 |
| Malaysia | 1 |
| India | 1 |
| United Kingdom | 1 |
Makers of Nephelometer, 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 |
|---|---|---|---|---|---|---|---|---|
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 1 | August 21, 1996 | 0 | 1 | 0 | api.fda.gov |
| Beckman Coulter Laboratory Systems (suzhou) Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | Cockeysville, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GFS Chemicals, Inc | Powell, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Manufacturing Sdn.Bhd. | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remel, Inc. | Lenexa, KS, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remel Cleveland, A Division of Remel Inc. | Oakwood Village, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Strumed Solutions Private Limited | Surat Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trek Diagnostic Systems, Ltd. | East Grinstead West Sussex, United Kingdom | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 21, 1996. 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.