Data / Medical devices / Apparatus, Electrophoresis, For Clinical Use
Apparatus, Electrophoresis, For Clinical Use (JJN): 15 FDA-registered makers in 9 countries
15 establishments in 9 countries are registered with the FDA to make Apparatus, Electrophoresis, For Clinical Use (product code JJN, Class 1, 21 CFR 862.2485). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on January 28, 1993, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JJN
- Device class
- 1
- Regulation
- 862.2485
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| China | 4 |
| United States | 3 |
| India | 2 |
| Germany | 1 |
| Malaysia | 1 |
| Singapore | 1 |
| Taiwan | 1 |
| France | 1 |
| Finland | 1 |
Makers of Apparatus, Electrophoresis, 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 |
|---|---|---|---|---|---|---|---|---|
| Agilent Technologies | Waldbronn Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agilent Technologies LDA | Penang Pulau Pinang, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agilent Technologies Singapore (International) Pte Ltd. | Singapore North East, Singapore | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biobase Biodustry(shandong)co., Ltd | Jinan Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioptic Inc. | New Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infitek Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labpeak Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marken Healthtech Limited | NASHIK Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| One Lambda, Inc. | West Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scitek Global Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sebia | EVRY Essonne, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wallac OY | TURKU Varsinais-Suomi, Finland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 28, 1993. 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.