Data / Medical devices / Hexokinase, Glucose / United States
FDA-registered makers of Hexokinase, Glucose in the United States: 16 establishments
16 establishments in the United States are registered with the FDA to make Hexokinase, Glucose (product code CFR). 12 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
- Hexokinase, Glucose
- Product code
- CFR
- Country
- United States
Makers of Hexokinase, Glucose in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Beckman Coulter, Inc. | Brea, CA, United States | Manufacturer, Specification developer | 3 | April 17, 2014 | 0 | 1 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Manufacturer, Specification developer | 2 | October 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | March 7, 2011 | 0 | 1 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 2 | February 8, 2000 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Abbott Park, IL, United States | Manufacturer | 1 | October 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Alfa Wassermann | West Caldwell, NJ, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | April 23, 2013 | 0 | 0 | 0 | api.fda.gov |
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer | 1 | October 15, 2001 | 0 | 0 | 0 | api.fda.gov |
| Carolina Liquid Chemistries | Brea, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | August 1, 1997 | 0 | 0 | 0 | api.fda.gov |
| Diazyme Laboratories, Inc. | Poway, CA, United States | Repackager or relabeler, Specification developer | 1 | December 1, 2011 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 1 | March 10, 1998 | 0 | 0 | 0 | api.fda.gov |
| Sanzay Corporation - | Miami Gardens, FL, United States | Remanufacturer, Repackager or relabeler | 1 | February 8, 2000 | 0 | 0 | 0 | api.fda.gov |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer | 1 | April 29, 1987 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 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.