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Data / Medical devices / System, Multipurpose For In Vitro Coagulation Studies / United States

FDA-registered makers of System, Multipurpose For In Vitro Coagulation Studies in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make System, Multipurpose For In Vitro Coagulation Studies (product code JPA). 16 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
System, Multipurpose For In Vitro Coagulation Studies
Product code
JPA
Country
United States

Makers of System, Multipurpose For In Vitro Coagulation Studies in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Instrumentation Laboratory Co.Bedford, MA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Specification developer15December 29, 2023040api.fda.gov
INSTRUMENTATION LABORATORY CO. - DevensDevens, MA, United StatesManufacturer for export, Repackager or relabeler8December 29, 2023000api.fda.gov
Accriva Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer, Manufacturer7December 29, 2021030api.fda.gov
Haemonetics CorporationBoston, MA, United StatesSpecification developer7April 30, 2025050api.fda.gov
Haemonetics CorporationClinton, PA, United StatesManufacturer, Manufacturer for export7April 30, 2025000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer5January 26, 2016020api.fda.gov
Helena Laboratories, Corp.Beaumont, TX, United StatesManufacturer, Manufacturer for export3May 10, 2006010api.fda.gov
Medtronic Perfusion SystemsParker, CO, United StatesManufacturer3July 30, 1998000api.fda.gov
Medtronic Perfusion SystemsMinneapolis, MN, United StatesSpecification developer2September 5, 1989000api.fda.gov
Sysmex America, Inc.Buffalo Grove, IL, United StatesManufacturer2January 26, 2016000api.fda.gov
Sysmex America, Inc. - Vernon HillsVernon Hills, IL, United StatesManufacturer2January 26, 2016000api.fda.gov
Coagusense IncFremont, CA, United StatesManufacturer1June 6, 2005000api.fda.gov
Helena Laboratories, Corp.Beaumont, TX, United StatesManufacturer, Manufacturer for export1July 11, 2005000api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer, Manufacturer for export1March 19, 2004000api.fda.gov
R & D Batteries, Inc.Burnsville, MN, United StatesManufacturer1December 3, 1993000api.fda.gov
Sienco, Inc.Boulder, CO, United StatesManufacturer, Manufacturer for export1September 5, 1995000api.fda.gov
Bionostics, Inc.Devens, MA, United StatesContract manufacturer0000api.fda.gov
HiArcMerrimack, NH, United StatesContract manufacturer0000api.fda.gov
Perosphere Technologies Inc.Danbury, CT, United StatesManufacturer for export0000api.fda.gov
Stellartech Research Corp.Milpitas, CA, United StatesManufacturer for export0000api.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.