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Data / Medical devices / Mixture, Hematology Quality Control / United States

FDA-registered makers of Mixture, Hematology Quality Control in the United States: 19 establishments

19 establishments in the United States are registered with the FDA to make Mixture, Hematology Quality Control (product code JPK). 10 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
Mixture, Hematology Quality Control
Product code
JPK
Country
United States

Makers of Mixture, Hematology Quality Control in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
R & D Systems, Inc.Minneapolis, MN, United StatesContract manufacturer, Manufacturer26September 1, 2016020api.fda.gov
Bio-Rad Laboratories Inc.Irvine, CA, United StatesManufacturer, Specification developer11January 29, 2010000api.fda.gov
Bio-Rad Laboratories Inc.Irvine, CA, United StatesManufacturer, Specification developer11January 29, 2010000api.fda.gov
Beckman Coulter, Inc.Miami, FL, United StatesManufacturer, Specification developer9February 3, 2009000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer4September 24, 2002000api.fda.gov
Streck LLCLa Vista, NE, United StatesContract manufacturer, Manufacturer2February 23, 2007000api.fda.gov
Bionostics, Inc.Devens, MA, United StatesManufacturer1September 19, 1985000api.fda.gov
Clinical Diagnostic Solutions, Inc.Plantation, FL, United StatesManufacturer, Repackager or relabeler1January 14, 2003030api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1April 24, 1980000api.fda.gov
Microgenics CorporationFremont, CA, United StatesManufacturer1September 19, 1985000api.fda.gov
Advanced Instruments, LLCNorwood, MA, United StatesManufacturer0000api.fda.gov
Beckman Coulter, Inc.Hialeah, FL, United StatesContract manufacturer0000api.fda.gov
Becton Dickinson Caribe, LTDCayey, PR, United StatesContract manufacturer0000api.fda.gov
Becton, Dickinson and Company, BD BiosciencesMilpitas, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer0000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer, Manufacturer for export, Remanufacturer0000api.fda.gov
Quantimetrix Corp.Redondo Beach, CA, United StatesContract manufacturer, Manufacturer0010api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Sure-Tech Diagnostic Associates, Inc.Saint Louis, MO, 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.