Data / Medical devices / System, Fibrinogen Determination / United States
FDA-registered makers of System, Fibrinogen Determination in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make System, Fibrinogen Determination (product code KQJ). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- System, Fibrinogen Determination
- Product code
- KQJ
- Country
- United States
Makers of System, Fibrinogen Determination 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 | 3 | July 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 1 | May 30, 1980 | 0 | 1 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 1 | May 2, 1984 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Bedford, MA, United States | Specification developer | 1 | July 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| R2 Diagnostics, Inc. | South Bend, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.