Data / Medical devices / Counter, Cell, Automated (Particle Counter)
Counter, Cell, Automated (Particle Counter) (GKL): 19 FDA-registered makers in 6 countries
19 establishments in 6 countries are registered with the FDA to make Counter, Cell, Automated (Particle Counter) (product code GKL, Class 2, 21 CFR 864.5200). 11 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 130 510(k) clearances under this code, the latest on May 27, 2016, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GKL
- Device class
- 2
- Regulation
- 864.5200
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| Japan | 2 |
| Sweden | 1 |
| Ireland | 1 |
| France | 1 |
| Lithuania | 1 |
Makers of Counter, Cell, Automated (Particle Counter)
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 |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 3 | December 7, 2005 | 0 | 2 | 0 | api.fda.gov |
| Sysmex Corporation Kakogawa Factory | Kakogawa Hyogo, Japan | Manufacturer | 2 | February 11, 2004 | 0 | 0 | 0 | api.fda.gov |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 2 | February 11, 2004 | 0 | 0 | 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 |
| Hemocue AB | ANGELHOLM Skane, Sweden | Manufacturer | 1 | October 25, 2007 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Manufacturing Ltd. | SWORDS Dublin(County), Ireland | Manufacturer | 1 | August 29, 1997 | 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 | |
| Horiba Abx SAS | MONTPELLIER Herault, France | 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 | |
| UAB Kitron | KAUNAS Kauno Apskritis, Lithuania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 27, 2016. 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.