FDA cleared the BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System from Becton, Dickinson and Company on Oct 31, 2025 under K250358, a traditional 510(k). The device falls under product code PCI, Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System, regulated at 21 CFR 866.3990 as a Class 2 device. The review panel was Microbiology.
FDA logged the submission as received on Feb 7, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Becton, Dickinson and Company has 8 other decisions in the tracker over the last 12 months: K260128 (BD Preset and BD A-Line Arterial Blood Collection Syringes), K252378 (BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube), K252506 (BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder), K252137 (BD Insyte IV Catheter).