FDA Product Code GIM: Tubes, Vacuum Sample, With Anticoagulant
FDA product code GIM covers vacuum sample tubes containing anticoagulants used for hematology testing.
These evacuated tubes contain EDTA, heparin, or sodium citrate anticoagulants that prevent blood clotting during collection and transport, preserving cell morphology and enabling accurate complete blood counts, coagulation studies, and blood film preparation.
GIM devices are Class II medical devices, regulated under 21 CFR 862.1675 and reviewed by the FDA Hematology panel.
Leading manufacturers include Becton, Dickinson and Company.
List of Tubes, Vacuum Sample, With Anticoagulant devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Tubes, Vacuum Sample, With Anticoagulant devices (product code GIM). 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 Hematology FDA review panel. Browse all Hematology devices →