FDA Product Code CFR: Hexokinase, Glucose
Leading manufacturers include Roche Diagnostics.
2
Total
2
Cleared
176d
Avg days
2022
Since
List of Hexokinase, Glucose devices cleared through 510(k)
2 devices
Cleared
Feb 12, 2026
Glucose HK Gen.3
Roche Diagnostics
Chemistry
111d
Cleared
Sep 16, 2022
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
Roche Diagnostics
Chemistry
241d
How to use this database
This page lists all FDA 510(k) submissions for Hexokinase, Glucose devices (product code CFR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →