Data / Medical devices / Cytocentrifuge
Cytocentrifuge (IFB): 14 FDA-registered makers in 6 countries
14 establishments in 6 countries are registered with the FDA to make Cytocentrifuge (product code IFB, Class 1, 21 CFR 864.3300). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on June 10, 1985, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IFB
- Device class
- 1
- Regulation
- 864.3300
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 3 |
| Germany | 2 |
| Brazil | 1 |
| Japan | 1 |
| India | 1 |
Makers of Cytocentrifuge
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 |
|---|---|---|---|---|---|---|---|---|
| Andreas Hettich GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Miami, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ELITechGroup Inc | Logan, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hologic, Inc. | Marlborough, MA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hunan Xiang Yi Laboratory Instrument Development Co., Ltd | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kolplast Ci Ltda | Itupeva Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard-Allan Scientific LLC | Kalamazoo, MI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Sakura Seiki Co., Ltd. | CHIKUMA-CITY Nagano, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Slee Medical GMBH | Nieder-Olm Rhineland-Palatinate, Germany | Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uni Meditrek Private Limited | Ghaziabad Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Landing Intelligence Medical Co.,Ltd | Wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Gene Science Co., Ltd | shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 10, 1985. 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.