Data / Medical devices / Activated Whole Blood Clotting Time
Activated Whole Blood Clotting Time (JBP): 10 FDA-registered makers in 2 countries
10 establishments in 2 countries are registered with the FDA to make Activated Whole Blood Clotting Time (product code JBP, Class 2, 21 CFR 864.7140). 9 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on January 4, 2023, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JBP
- Device class
- 2
- Regulation
- 864.7140
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Canada | 1 |
Makers of Activated Whole Blood Clotting Time
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 |
|---|---|---|---|---|---|---|---|---|
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Specification developer | 4 | September 21, 1992 | 0 | 1 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Parker, CO, United States | Manufacturer | 4 | September 21, 1992 | 0 | 0 | 0 | api.fda.gov |
| Sienco, Inc. | Boulder, CO, United States | Manufacturer | 4 | January 4, 2023 | 0 | 0 | 0 | api.fda.gov |
| Accriva Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 3 | August 12, 1996 | 0 | 1 | 0 | api.fda.gov |
| Abbott Point Of Care Canada Limited | Ottawa Ontario, Canada | Manufacturer | 2 | September 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 2 | May 23, 2002 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer, Manufacturer for export | 2 | December 11, 1998 | 0 | 0 | 0 | api.fda.gov |
| Haemonetics Corporation | Boston, MA, United States | Specification developer | 1 | January 31, 2007 | 0 | 0 | 0 | api.fda.gov |
| Haemonetics Corporation | Clinton, PA, United States | Manufacturer | 1 | January 31, 2007 | 0 | 0 | 0 | api.fda.gov |
| Abbott Point Of Care Inc. | Princeton, NJ, United States | Manufacturer, Specification developer | 0 | 0 | 4 | 0 | api.fda.gov |
Updated January 4, 2023. 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.