Data / Medical devices / Stainer, Tissue, Automated
Stainer, Tissue, Automated (KEY): 9 FDA-registered makers in 6 countries
9 establishments in 6 countries are registered with the FDA to make Stainer, Tissue, Automated (product code KEY, Class 1, 21 CFR 864.3800). 0 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on October 5, 1977, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KEY
- Device class
- 1
- Regulation
- 864.3800
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| India | 1 |
| Spain | 1 |
| Germany | 1 |
| Pakistan | 1 |
| China | 1 |
Makers of Stainer, Tissue, Automated
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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Molecular, Inc. | Des Plaines, IL, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Auxein medical Private limited | Sonipat Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biogenex Laboratories Inc. | Fremont, CA, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Especialidades Medicas Myr SL | Llorenc del Pendes Tarragona, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Slee Medical GMBH | Nieder-Olm Rhineland-Palatinate, Germany | Complaint file establishment, Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ted Pella, Inc. | Redding, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volusol | Tooele, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Win Wings Corp. | SIALKOT Punjab, Pakistan | 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 |
Updated October 5, 1977. 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.