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— 510(k) K250358
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K250358 for 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, Substantially Equivalent on 2025-10-31. Applicant: Becton, Dickinson and Company. Device class: 2.
Clearance details
- Applicant
- Becton, Dickinson and Company
- Product code
- Code PCI
- Device class
- Class 2
- Regulation
- 21 CFR 866.3990
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
Recent devices under product code PCI
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Data sourced from openFDA. This site is unofficial and independent of the FDA.