Data / Medical devices / Preservative, Cytological / United States
FDA-registered makers of Preservative, Cytological in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Preservative, Cytological (product code LEA). 0 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Preservative, Cytological
- Product code
- LEA
- Country
- United States
Makers of Preservative, Cytological in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cellsolutions LLC | Greensboro, NC, United States | Complaint file establishment, Manufacturer for export, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cancer Diagnostics, Inc. | Durham, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hologic, Inc. | Marlborough, MA, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Hologic, Inc. | Londonderry, NH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infrared Laboratory Systems dba SYNERMED | Westfield, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lonza Walkersville, Inc. | Walkersville, MD, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Biosystems Richmond, Inc. | Richmond, IL, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Richard-Allan Scientific LLC | Kalamazoo, MI, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| SLMP LLC d.b.a. StatLab Medical Products | McKinney, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SSN Solutions | Henrico, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Streck LLC | La Vista, NE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zeptometrix LLC. | Buffalo, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.