510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250358Substantially Equivalent

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

Becton Dickinson & Co, Sparks MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250358 is the FDA 510(k) clearance record 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, a class II device, cleared for Becton, Dickinson and Company on under FDA product code PCI (Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System). FDA's definition for product code PCI reads: "A gastrointestinal bacterial panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool...". FDA records list 345 510(k) clearances for Becton, Dickinson and Company, from to . As of , FDA records show no recalls naming K250358.

Clearance record

Decision date
Received
(266 days to decision)
Product code
PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
Regulation
21 CFR 866.3990
Device class
Class II
Review panel
Microbiology
Applicant
Becton, Dickinson and Company 7loveton Cir., Sparks MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PCI

Trailing 12 months

FDA records hold no clearances under product code PCI in the trailing twelve months.

FDA records show no clearances under product code PCI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PCI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260