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Data / Medical devices / System, Automated Platelet Aggregation / United States

FDA-registered makers of System, Automated Platelet Aggregation in the United States: 5 establishments

5 establishments in the United States are registered with the FDA to make System, Automated Platelet Aggregation (product code JOZ). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device
System, Automated Platelet Aggregation
Product code
JOZ
Country
United States

Makers of System, Automated Platelet Aggregation in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Accriva Diagnostics, Inc.San Diego, CA, United StatesManufacturer, Manufacturer for export5July 24, 2015030api.fda.gov
Chrono-Log Corp.Havertown, PA, United StatesManufacturer, Repackager or relabeler4December 2, 2016000api.fda.gov
Haemonetics CorporationBoston, MA, United StatesSpecification developer2January 3, 2015000api.fda.gov
Helena Laboratories, Corp.Beaumont, TX, United StatesManufacturer2February 14, 2003000api.fda.gov
Haemonetics CorporationClinton, PA, United StatesManufacturer, Manufacturer for export2January 3, 2015000api.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.