Data / Medical devices / Stains, Chemical Solution
Stains, Chemical Solution (LED): 19 FDA-registered makers in 7 countries
19 establishments in 7 countries are registered with the FDA to make Stains, Chemical Solution (product code LED, Class 1, 21 CFR 864.1850). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on August 8, 2005, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LED
- Device class
- 1
- Regulation
- 864.1850
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| China | 1 |
| Germany | 1 |
| Italy | 1 |
| Canada | 1 |
| Belgium | 1 |
| France | 1 |
Makers of Stains, Chemical Solution
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 |
|---|---|---|---|---|---|---|---|---|
| CalibreScientific US, Inc. | Vancouver, WA, United States | Manufacturer | 1 | October 31, 1985 | 0 | 0 | 0 | api.fda.gov |
| ANATECH division of Cancer Diagnostics, Inc. | Battle Creek, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ave Science & Technology Co., Ltd | Changsha Hunan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Azer Scientific, Inc. | Morgantown, PA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Gram Diagnostics GMBH | Worms Rhineland-Palatinate, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Optica Milano SPA | Milano, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chaptec America | Montreal Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creative Waste Solutions, Inc. | Tualatin, OR, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cancer Diagnostics, Inc. | Durham, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E K Industries, Inc. | Joliet, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fertility Solutions, Inc. | Warrensville Heights, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fertipro N.V. | BEERNEM West-Vlaanderen, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horiba Abx SAS | MONTPELLIER Herault, France | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Newcomer Supply Inc | Waunakee, WI, United States | Specification developer | 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 | |
| Sigma-Aldrich Manufacturing, LLC-H&H | Saint Louis, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SLMP LLC d.b.a. StatLab Medical Products | McKinney, TX, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ventana Medical Systems, Inc. | Tucson, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 8, 2005. 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.