Data / Medical devices / Aggregrometer, Platelet
Aggregrometer, Platelet (JBX): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Aggregrometer, Platelet (product code JBX, Class 2, 21 CFR 864.6675). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on November 2, 1993, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JBX
- Device class
- 2
- Regulation
- 864.6675
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| France | 1 |
Makers of Aggregrometer, Platelet
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 |
|---|---|---|---|---|---|---|---|---|
| Chrono-Log Corp. | Havertown, PA, United States | Manufacturer, Repackager or relabeler | 2 | November 2, 1993 | 0 | 0 | 0 | api.fda.gov |
| Diagnostica Stago - Taverny | Taverny Val-d'Oise, France | Exporter to the US, Manufacturer | 1 | October 22, 1986 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 1 | August 22, 1991 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 1993. 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.