FDA Product Code NBW: System, Test, Blood Glucose, Over The Counter
FDA product code NBW covers over-the-counter blood glucose test systems for home use by people with diabetes.
These systems — comprising a meter and test strips — allow patients to measure their blood glucose level from a small fingertip blood sample in seconds. Results guide insulin dosing decisions, dietary choices, and the management of hypoglycemic and hyperglycemic episodes.
NBW devices are Class II medical devices, regulated under 21 CFR 862.1345 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Apex BioTechnology Corp., Bionime Corporation and I-Sens, Inc..
List of System, Test, Blood Glucose, Over The Counter devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, Test, Blood Glucose, Over The Counter devices (product code NBW). 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 →