Data / Medical devices / System, Automated Platelet Aggregation
System, Automated Platelet Aggregation (JOZ): 12 FDA-registered makers in 5 countries
12 establishments in 5 countries are registered with the FDA to make System, Automated Platelet Aggregation (product code JOZ, Class 2, 21 CFR 864.5700). 9 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 38 510(k) clearances under this code, the latest on February 14, 2020, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JOZ
- Device class
- 2
- Regulation
- 864.5700
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Germany | 2 |
| Japan | 2 |
| Australia | 2 |
| Taiwan | 1 |
Makers of System, Automated Platelet Aggregation
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Accriva Diagnostics, Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 5 | July 24, 2015 | 0 | 3 | 0 | api.fda.gov |
| Chrono-Log Corp. | Havertown, PA, United States | Manufacturer, Repackager or relabeler | 4 | December 2, 2016 | 0 | 0 | 0 | api.fda.gov |
| Haemonetics Corporation | Boston, MA, United States | Specification developer | 2 | January 3, 2015 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 2 | February 14, 2003 | 0 | 0 | 0 | api.fda.gov |
| Haemonetics Corporation | Clinton, PA, United States | Manufacturer, Manufacturer for export | 2 | January 3, 2015 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer, Specification developer | 2 | July 21, 2006 | 0 | 0 | 0 | api.fda.gov |
| Sunphoria Co., Ltd. | Taipei City, Taiwan | Specification developer | 1 | February 14, 2020 | 0 | 0 | 0 | api.fda.gov |
| Zacros Corporation | Tokyo, Japan | Complaint file establishment, Exporter to the US, Specification developer | 1 | February 14, 2020 | 0 | 0 | 0 | api.fda.gov |
| Zacros Corporation Mie Facility | NABARI CITY Mie, Japan | Manufacturer | 1 | February 14, 2020 | 0 | 0 | 0 | api.fda.gov |
| BIT Analytical Solutions GmbH | SCHWALBACH/TAUNUS Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Invetech Pty Ltd | Mount Waverley Victoria, Australia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Biosystems Melbourne Pty Ltd | MELBOURNE Victoria, Australia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 14, 2020. 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.