Data / Medical devices / Calibrator, Primary / United States

FDA-registered makers of Calibrator, Primary in the United States: 26 establishments

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

26 establishments in the United States are registered with the FDA to make Calibrator, Primary (product code JIS). 12 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: Calibrator, Primary
Product code: JIS
Country: United States

Makers of Calibrator, Primary in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Siemens Healthcare Diagnostics Inc.	Newark, DE, United States	Manufacturer, Specification developer	5	May 31, 2006	2	api.fda.gov
Beckman Coulter, Inc.	Brea, CA, United States	Specification developer	3	February 10, 2000	6	api.fda.gov
Fisher Diagnostics	Middletown, VA, United States	Contract manufacturer, Manufacturer, Specification developer	2	October 16, 2001	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Complaint file establishment, Manufacturer, Specification developer	2	August 13, 2003	0	api.fda.gov
Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, United States	Complaint file establishment, Specification developer	2	August 14, 2012	0	api.fda.gov
Verichem Laboratories, Inc.	Providence, RI, United States	Contract manufacturer, Manufacturer	2	January 13, 1993	0	api.fda.gov
Analytical Control Systems	Fishers, IN, United States	Manufacturer	1	June 7, 1993	0	api.fda.gov
Cliniqa Corporation	San Marcos, CA, United States	Manufacturer	1	August 29, 1988	0	api.fda.gov
ELITechGroup Inc	Logan, UT, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	1	October 21, 2003	0	api.fda.gov
Hemagen Diagnostics, Inc.	Baltimore, MD, United States	Manufacturer	1	November 29, 1988	0	api.fda.gov
Horiba Instruments Incorporated	Canton, MI, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	1	September 28, 2001	0	api.fda.gov
Instrumentation Laboratory Co.	Orangeburg, NY, United States	Manufacturer	1	June 6, 2003	0	api.fda.gov
Alfa Wassermann	West Caldwell, NJ, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Axiom Diagnostics, Inc.	Tampa, FL, United States	Manufacturer	0		0	api.fda.gov
Beckman Coulter, Inc.	Chaska, MN, United States	Manufacturer	0		0	api.fda.gov
Beckman Coulter, Inc.	Carlsbad, CA, United States	Contract manufacturer	0		0	api.fda.gov
BiometerPlus USA, Inc.	Fremont, CA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Catachem, Inc.	Oxford, CT, United States	Manufacturer	0		0	api.fda.gov
High Technology, Inc.	North Attleboro, MA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Kamiya Biomedical Company LLC	Tukwila, WA, United States	Manufacturer	0		0	api.fda.gov
Microgenics Corporation	Fremont, CA, United States	Manufacturer	0		0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Manufacturer, Manufacturer for export, Repackager or relabeler	0		0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Manufacturer	0		0	api.fda.gov
Precision Diabetes, Inc.	Raleigh, NC, United States	Specification developer	0		0	api.fda.gov
Siemens Healthcare Diagnostics Inc.	E Walpole, MA, United States	Manufacturer	0		3	api.fda.gov
Teco Diagnostics	Anaheim, CA, United States	Manufacturer, Repackager or relabeler	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.