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Data / Medical devices / Calibrator, Secondary / United States

FDA-registered makers of Calibrator, Secondary in the United States: 42 establishments

42 establishments in the United States are registered with the FDA to make Calibrator, Secondary (product code JIT). 16 have a 510(k) clearance or PMA approval on file and 10 have a recall event. FDA data exported November 2, 2026.

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Device
Calibrator, Secondary
Product code
JIT
Country
United States

Makers of Calibrator, Secondary in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Specification developer27April 5, 2013070api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesManufacturer11August 8, 2014000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer6November 17, 2016030api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesContract manufacturer, Manufacturer, Specification developer5August 19, 2011000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer4May 16, 2017030api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer, Manufacturer for export, Specification developer3November 9, 2005000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler3December 9, 2004050api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesSpecification developer3September 11, 2001000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2June 26, 2013000api.fda.gov
Qualigen, Inc.Carlsbad, CA, United StatesManufacturer2September 30, 2002000api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer2June 2, 2011020api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer1February 26, 2015040api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesContract manufacturer, Manufacturer1March 21, 2006000api.fda.gov
Diazyme Laboratories, Inc.Poway, CA, United StatesManufacturer1June 26, 2013000api.fda.gov
Hemagen Diagnostics, Inc.Baltimore, MD, United StatesManufacturer1May 2, 2001000api.fda.gov
Verichem Laboratories, Inc.Providence, RI, United StatesContract manufacturer, Manufacturer1October 25, 1988000api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer0010api.fda.gov
Abbott LaboratoriesAbbott Park, IL, United StatesSpecification developer0040api.fda.gov
Alden Medical LLCW Springfield, MA, United StatesContract manufacturer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer0000api.fda.gov
Bio-Rad Laboratories, Inc.Woodinville, WA, United StatesContract manufacturer0000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesComplaint file establishment, Specification developer0010api.fda.gov
BiomericaIrvine, CA, United StatesManufacturer for export0000api.fda.gov
Currier PlasticsAuburn, NY, United StatesContract manufacturer0000api.fda.gov
Diagnostica Stago, Inc.Parsippany, NJ, United StatesManufacturer for export0000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesContract manufacturer0000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Exact DiagnosticsFort Worth, TX, United StatesManufacturer0000api.fda.gov
Fujirebio Diagnostics, Inc.Malvern, PA, United StatesContract manufacturer0000api.fda.gov
Fujirebio Diagnostics, Inc.Seguin, TX, United StatesContract manufacturer, Manufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Inova Diagnostics, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer0000api.fda.gov
Kamiya Biomedical Company LLCTukwila, WA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer0010api.fda.gov
Microgenics CorporationFremont, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Nypro Inc. (Chicago)Gurnee, IL, United StatesContract manufacturer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
SCITECK DiagnosticsFletcher, NC, United StatesManufacturer0000api.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.