Data / Medical devices / System, Suspension, Cell Culture
System, Suspension, Cell Culture (KJF): 14 FDA-registered makers in 6 countries
14 establishments in 6 countries are registered with the FDA to make System, Suspension, Cell Culture (product code KJF, Class 1, 21 CFR 864.2240). 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 June 23, 1989, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KJF
- Device class
- 1
- Regulation
- 864.2240
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Israel | 1 |
| China | 1 |
| Taiwan | 1 |
| Turkey | 1 |
| South Korea | 1 |
Makers of System, Suspension, Cell Culture
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 |
|---|---|---|---|---|---|---|---|---|
| Adva Biotechnology | Bar-Lev High-Tech Park Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aivita Biomedical, Inc. | Irvine, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Charter Medical, LLC | Winston Salem, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Corning-Kennebunk | Kennebunk, ME, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diatrust Medical Co., Ltd. | Nanjing City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eirmed, LLC | Menomonie, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Esco Bioengineering | Taichung, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Biyomedikal Saglik Hizmetleri Sanayi Ve Ticaret Limited Sirketi | BAHCELIEVLER Istanbul, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healthy Solutions, LLC | Scottsdale, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDIKAN CO., Ltd. | Gangseo-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smart Practice | Phoenix, AZ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trelleborg Sealing Solutions River Falls | River Falls, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vonco Products, LLC | Fortville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wilson Wolf Manufacturing LLC | New Brighton, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 23, 1989. 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.