Data / Medical devices / Activated Partial Thromboplastin / United States
FDA-registered makers of Activated Partial Thromboplastin in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Activated Partial Thromboplastin (product code GFO). 4 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Activated Partial Thromboplastin
- Product code
- GFO
- Country
- United States
Makers of Activated Partial Thromboplastin in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer | 4 | March 16, 2016 | 0 | 0 | 0 | api.fda.gov |
| Accriva Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 1 | November 20, 1997 | 0 | 1 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 1 | April 21, 1989 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer, Manufacturer for export | 1 | February 14, 1992 | 0 | 2 | 0 | api.fda.gov |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.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.