Data / Medical devices / Separator, Automated, Blood Cell, Diagnostic / United States
FDA-registered makers of Separator, Automated, Blood Cell, Diagnostic in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Separator, Automated, Blood Cell, Diagnostic (product code GKT). 3 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
- Separator, Automated, Blood Cell, Diagnostic
- Product code
- GKT
- Country
- United States
Makers of Separator, Automated, Blood Cell, Diagnostic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fenwal, Inc. | Lake Zurich, IL, United States | Complaint file establishment, Specification developer | 2 | September 11, 2020 | 0 | 1 | 0 | api.fda.gov |
| Fresenius Kabi Warrendale | Warrendale, PA, United States | Manufacturer, Manufacturer for export, Remanufacturer | 2 | September 11, 2020 | 0 | 0 | 0 | api.fda.gov |
| Terumo BCT, Inc.. | Lakewood, CO, United States | Manufacturer, Specification developer | 1 | January 10, 1977 | 0 | 0 | 0 | api.fda.gov |
| Comar, LLC | Buena, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comar | Rancho Cucamonga, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fenwal International, Inc. | San German, PR, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GVS TM, Inc. | Covina, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemonetics Corporation | Boston, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemonetics Corporation | Clinton, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemonetics Corporation | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | San Diego, CA, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| TERUMO BCT, INC.- Littleton | Highlands Ranch, CO, United States | Contract 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.