DeviceClearance

K062945

Substantially Equivalent

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML

Applicant
Becton, Dickinson & CO
Product code
LON
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sparks, MD, US
Download summary PDF View 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.