Data / Medical devices / Flask, Tissue Culture
Flask, Tissue Culture (KJA): 19 FDA-registered makers in 4 countries
19 establishments in 4 countries are registered with the FDA to make Flask, Tissue Culture (product code KJA, 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 13 510(k) clearances under this code, the latest on July 22, 1997, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KJA
- Device class
- 1
- Regulation
- 864.2240
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| China | 9 |
| United States | 8 |
| South Korea | 1 |
| Germany | 1 |
Makers of Flask, 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 | |
| Corning Incorporated Discovery Labware | Durham, NC, United States | Complaint file establishment, Contract sterilizer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diatrust Medical Co., Ltd. | Nanjing City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Holocraft Corporation dba Flexcraft Company | Neptune City, NJ, 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 | |
| OriGen Biomedical, Inc. | Austin, TX, United States | Complaint file establishment, 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 | |
| Sarstedt AG & Co. KG | NUMBRECHT North Rhine-Westphalia, Germany | 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 | |
| Suzhou Cellpro Biotechnology Co.,ltd. | Suzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trummed Medical (hangzhou) Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Watauga Opportunities, Inc. | Boone, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuxi Nest Biotechnology Co., Ltd | Wuxi Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Saining Biotechnology Co.,ltd | Taizhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Sorfa Life Science Research Co., Ltd. | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 22, 1997. 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.