Data / Medical devices / Formulations, Paraffin, All
Formulations, Paraffin, All (KEO): 21 FDA-registered makers in 7 countries
21 establishments in 7 countries are registered with the FDA to make Formulations, Paraffin, All (product code KEO, Class 1, 21 CFR 864.4010). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on June 22, 1989, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KEO
- Device class
- 1
- Regulation
- 864.4010
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| China | 5 |
| Germany | 2 |
| Italy | 1 |
| United Kingdom | 1 |
| India | 1 |
| Australia | 1 |
Makers of Formulations, Paraffin, All
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 |
|---|---|---|---|---|---|---|---|---|
| Biogenex Laboratories Inc. | Fremont, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CITOTEST Labware Manufacturing CO., LTD. | Haimen Jiangsu, China | Manufacturer, Repackager or relabeler | 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 | |
| Cancer Diagnostics, Inc. | Durham, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dakewe(shenzhen) Medical Equipment Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diapath S.P.A. | Martinengo Bergamo, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diatrust Medical Co., Ltd. | Nanjing City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| General Data Healthcare | Cincinnati, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Huida Medical Instruments Co., Ltd | Yancheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Biosystems Richmond, Inc. | Richmond, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Chemical Corporation | Torrance, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medite Medical GMBH | Burgdorf Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merck Kgaa | DARMSTADT Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North Coast Medical, Inc. | Morgan Hill, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polysciences, Inc. | Warrington, PA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Poth Hille & Co Ltd | Rainham Essex, United Kingdom | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard-Allan Scientific LLC | Kalamazoo, MI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sakura Finetek U.s.a., Inc. | Torrance, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Sidman Industries | SHAHJAHANPUR, ALWAR Rajasthan, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SLMP LLC d.b.a. StatLab Medical Products | McKinney, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trajan Scientific Australia Pty Ltd | Ringwood Victoria, Australia | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 22, 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.