Data / Medical devices / Counter, Cell, Automated (Particle Counter) / United States
FDA-registered makers of Counter, Cell, Automated (Particle Counter) in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Counter, Cell, Automated (Particle Counter) (product code GKL). 7 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Counter, Cell, Automated (Particle Counter)
- Product code
- GKL
- Country
- United States
Makers of Counter, Cell, Automated (Particle Counter) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 3 | December 7, 2005 | 0 | 2 | 0 | api.fda.gov |
| Sysmex America, Inc. | Buffalo Grove, IL, United States | Manufacturer | 2 | February 11, 2004 | 0 | 0 | 0 | api.fda.gov |
| Sysmex America, Inc. - Vernon Hills | Vernon Hills, IL, United States | Manufacturer | 2 | February 11, 2004 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instruments, LLC | Norwood, MA, United States | Manufacturer | 1 | May 27, 2016 | 0 | 1 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Miami, FL, United States | Specification developer | 1 | March 23, 2005 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson and Company, BD Biosciences | Milpitas, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | March 21, 1988 | 0 | 0 | 0 | api.fda.gov |
| HAMILTON THORNE, Inc. | Beverly, MA, United States | Manufacturer | 1 | June 29, 1992 | 0 | 0 | 0 | api.fda.gov |
| Antibodies Incorporated | Davis, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Chaska, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton Dickinson Caribe, LTD | Cayey, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Streck LLC | La Vista, NE, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.