K250358
- 510(k) number
- K250358
- Device name
- 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
- Applicant
- Becton, Dickinson and Company MD · US
- Product code
- PCI — Gastrointestinal Bacterial Panel Multiplex Nucleic A
- Decision date
- 2025-10-31
- Date received
- 2025-02-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K250358.pdf
Official FDA record: K250358
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.