BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML)— 510(k) K140468

Substantially Equivalent

Becton, Dickinson and Company

FDA 510(k) clearance K140468 for BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML), Substantially Equivalent on 2014-06-02. Applicant: Becton, Dickinson and Company.

Clearance details

Applicant
Becton, Dickinson and Company
Product code
Code LON
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sparks, MD, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LON

product code LON
Malfunction
2,383
Total
2,383

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.