Data / Medical devices / Slide Stainer, Automated / United States

FDA-registered makers of Slide Stainer, Automated in the United States: 23 establishments

Name: FDA-registered makers of Slide Stainer, Automated in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

23 establishments in the United States are registered with the FDA to make Slide Stainer, Automated (product code KPA). 2 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: Slide Stainer, Automated
Product code: KPA
Country: United States

Makers of Slide Stainer, Automated in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, United States	Complaint file establishment, Specification developer	1	August 25, 1977	0	api.fda.gov
Siemens Healthcare Diagnostics, Inc.	Mishawaka, IN, United States	Manufacturer	1	August 25, 1977	0	api.fda.gov
Abbott Laboratories	Irving, TX, United States	Specification developer	0		0	api.fda.gov
Asp Health Inc.	Northbrook, IL, United States	Specification developer	0		0	api.fda.gov
Auer Precision	Mesa, AZ, United States	Contract manufacturer	0		0	api.fda.gov
Agilent Technologies, Inc	Santa Clara, CA, United States	Specification developer	0		0	api.fda.gov
Agilent Technologies, Inc.	Carpinteria, CA, United States	Manufacturer, Specification developer	0		3	api.fda.gov
Beckman Coulter, Inc.	Miami, FL, United States	Manufacturer	0		0	api.fda.gov
Biocare Medical, LLC	Pacheco, CA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		1	api.fda.gov
Biogenex Laboratories Inc.	Fremont, CA, United States	Manufacturer	0		0	api.fda.gov
ELITechGroup Inc	Logan, UT, United States	Manufacturer	0		0	api.fda.gov
Hologic, Inc.	Marlborough, MA, United States	Specification developer	0		0	api.fda.gov
Hardy Diagnostics	Springboro, OH, United States	Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Lumatas Biosystems, Inc	Milpitas, CA, United States	Manufacturer	0		0	api.fda.gov
Novodiax, Inc.	Hayward, CA, United States	Manufacturer	0		0	api.fda.gov
Pathcom Systems Corporation	Dublin, CA, United States	Manufacturer	0		0	api.fda.gov
Rushabh Instruments, LLC	Ivyland, PA, United States	Manufacturer	0		0	api.fda.gov
Sakura Finetek U.s.a., Inc.	Torrance, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Sigma-Aldrich Corp.	Saint Louis, MO, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Sysmex America, Inc.	Buffalo Grove, IL, United States	Manufacturer	0		0	api.fda.gov
Sysmex America, Inc. - Vernon Hills	Vernon Hills, IL, United States	Manufacturer	0		0	api.fda.gov
Ventana Medical Systems, Inc.	Tucson, AZ, United States	Manufacturer	0		6	api.fda.gov
Volusol	Tooele, UT, United States	Manufacturer	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.