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Data / Medical devices / Counter, Differential Cell / United States

FDA-registered makers of Counter, Differential Cell in the United States: 18 establishments

18 establishments in the United States are registered with the FDA to make Counter, Differential Cell (product code GKZ). 13 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.

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Device
Counter, Differential Cell
Product code
GKZ
Country
United States

Makers of Counter, Differential Cell in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Beckman Coulter, Inc.Miami, FL, United StatesManufacturer, Specification developer40July 5, 2024010api.fda.gov
Becton, Dickinson and Company, BD BiosciencesMilpitas, CA, United StatesComplaint file establishment, Manufacturer, Specification developer25July 31, 2009020api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Repackager or relabeler, Specification developer10May 21, 2024040api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer9February 20, 2025000api.fda.gov
Sysmex America, Inc.Buffalo Grove, IL, United StatesContract manufacturer, Manufacturer8June 25, 2025000api.fda.gov
Sysmex America, Inc. - Vernon HillsVernon Hills, IL, United StatesContract manufacturer, Manufacturer8June 25, 2025000api.fda.gov
Abbott LaboratoriesAbbott Park, IL, United StatesSpecification developer3March 15, 2019020api.fda.gov
AthelasMountain View, CA, United StatesManufacturer3February 6, 2026000api.fda.gov
Drucker Diagnostics, LLCPhilipsburg, PA, United StatesComplaint file establishment, Manufacturer, Remanufacturer3September 23, 1999000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler, Reprocessor3September 1, 2016000api.fda.gov
R & D Systems, Inc.Minneapolis, MN, United StatesManufacturer2July 20, 1998000api.fda.gov
JAS Diagnostics/Drew ScientificPlantation, FL, United StatesSpecification developer1December 11, 2007040api.fda.gov
Streck LLCLa Vista, NE, United StatesContract manufacturer, Manufacturer1October 12, 2015000api.fda.gov
Antibodies IncorporatedDavis, CA, United StatesContract manufacturer0000api.fda.gov
Beckman Coulter, Inc.Hialeah, FL, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Becton Dickinson Caribe, LTDCayey, PR, United StatesContract manufacturer0000api.fda.gov
Cytek Biosciences, Inc.Fremont, CA, United StatesManufacturer for export0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.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.