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FDA 510(k)

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

K-Number: K250358 · 2025-10-31

ApplicantBecton, Dickinson and Company
Decision Date2025-10-31
Product CodePCI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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 is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2025-10-31 under approval number K250358. The device is classified under product code PCI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is 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?

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 is a medical device that received FDA 510(k) clearance on 2025-10-31. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K250358.

When was 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 approved by the FDA?

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 received FDA 510(k) clearance on 2025-10-31, under approval number K250358.

What company makes 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?

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 is manufactured by Becton, Dickinson and Company.

What is the FDA product code 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?

The FDA product code 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 is PCI.

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

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Related Devices (Code: PCI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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