FDA Product Code JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection
Under FDA product code JKA, blood collection tubes, vials, and serum separator systems are cleared for the collection and processing of clinical specimens.
These devices include evacuated tubes with various additives — anticoagulants, gels, clot activators — that preserve specimen integrity for specific laboratory tests. Serum separators use a gel barrier to separate serum from clot after centrifugation, simplifying sample processing.
JKA devices are Class II medical devices, regulated under 21 CFR 862.1675 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Becton, Dickinson and Company, Jiangsu Caina Medical Co.,Ltd and Becton Dickinson Infusion Therapy Systems, Inc..
List of Tubes, Vials, Systems, Serum Separators, Blood Collection devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Tubes, Vials, Systems, Serum Separators, Blood Collection devices (product code JKA). 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 General Hospital FDA review panel. Browse all General Hospital devices →