Data / Medical devices / Electrophoretic Separation, Lipoproteins
Electrophoretic Separation, Lipoproteins (JHO): 4 FDA-registered makers in 2 countries
4 establishments in 2 countries are registered with the FDA to make Electrophoretic Separation, Lipoproteins (product code JHO, Class 1, 21 CFR 862.1475). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 26 510(k) clearances under this code, the latest on August 15, 2002, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JHO
- Device class
- 1
- Regulation
- 862.1475
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| France | 1 |
Makers of Electrophoretic Separation, Lipoproteins
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 |
|---|---|---|---|---|---|---|---|---|
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 2 | December 21, 2001 | 0 | 0 | 0 | api.fda.gov |
| Quantimetrix Corp. | Redondo Beach, CA, United States | Manufacturer | 2 | March 8, 2002 | 0 | 0 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer | 1 | April 15, 1998 | 0 | 0 | 0 | api.fda.gov |
| Sebia | EVRY Essonne, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 15, 2002. 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.