Data / Medical devices / Bottle, Roller, Tissue Culture
Bottle, Roller, Tissue Culture (KJC): 11 FDA-registered makers in 3 countries
11 establishments in 3 countries are registered with the FDA to make Bottle, Roller, Tissue Culture (product code KJC, 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 3 510(k) clearances under this code, the latest on April 1, 1988, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KJC
- Device class
- 1
- Regulation
- 864.2240
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| China | 5 |
| United States | 5 |
| Switzerland | 1 |
Makers of Bottle, Roller, Tissue 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 |
|---|---|---|---|---|---|---|---|---|
| CITOTEST Labware Manufacturing CO., LTD. | Haimen Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Citotest Scientific Co.,ltd. | Nanjing Jiangsu, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Corning-Kennebunk | Kennebunk, ME, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Corning-Oneonta | Oneonta, NY, 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 | |
| REGEN LAB Sa | LE MONT-SUR-LAUSANNE Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Regenlab USA LLC | Jersey City, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saint-Gobain Performance Plastics Corporation | Largo, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Cellpro Biotechnology Co.,ltd. | Suzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trademark Plastics Inc. | Riverside, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Gongdong Medical Technology Co., Ltd | TAIZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 1, 1988. 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.